MSI Stent Securement Testing Overview

Machine Solutions Inc
26 Apr 201219:49

Summary

TLDRIn this presentation, Melissa Lockwitzer from Machine Solutions discusses the importance of stent securement testing for patient safety and regulatory compliance. She compares three methods—shim, tape, and the MSI SR-1000—evaluating their ease of setup, operation, and data consistency. The SR-1000 stands out for its automation, precision, and reduced variability in results. Lockwitzer highlights how the SR-1000 offers more consistent and efficient testing than traditional methods, emphasizing its advantages in improving stent testing practices. The presentation also includes a demonstration of the SR-1000 in action.

Takeaways

  • 🩺 The presentation is by Melissa Lockwitzer, focusing on stent securement testing methods and their importance.
  • 🏥 Stent securement testing is crucial for patient safety and is required by the FDA to ensure that stents reach the intended treatment site without issues.
  • ⚙️ Three different stent securement methods are compared: the shim method, the tape method, and the SR-1000 by MSI.
  • 🔧 The SR-1000 is the most automated of the three methods, launched last year by Machine Solutions (MSI), and features segmental compression technology.
  • 📊 The tape method shows the highest standard deviation and requires significant setup time, often leading to misleadingly high retention forces.
  • 📉 The SR-1000 had the lowest standard deviation (0.06 lbs) and the most consistent results in terms of stent securement forces.
  • ⏳ Setup time comparison: The tape method takes over 6 minutes, the shim method takes around 3 minutes, and the SR-1000 takes only 1 to 1.5 minutes.
  • 🔍 The SR-1000 integrates a video system that links to the test data, helping to identify the exact moment of stent dislodgement.
  • 📐 The SR-1000 also provides control over diameter and force, minimizing operator variability and ensuring a more accurate stent securement test.
  • 🚀 The conclusion suggests that the longstanding belief about minimum retention forces may be based on the outdated tape method and should be reconsidered.

Q & A

  • What is the primary purpose of stent securement testing?

    -The primary purpose of stent securement testing is to ensure that balloon-expandable stents are securely crimped onto the delivery system, making sure they reach the intended treatment site safely and function effectively. This testing is crucial for patient safety, as failure to secure the stent can result in serious complications, including prolonged procedures or even open-heart surgery.

  • What are the three failure modes discussed in the presentation?

    -The three failure modes discussed are: 1) Straight dislodgement, where the stent moves outside the proximal and distal marker bands, causing issues with deployment. 2) Stent compression or buckling, which can cause vessel damage or perforation. 3) Complete dislodgement of the stent, where it detaches from the delivery system and can lead to severe complications such as the need for open-heart surgery.

  • What are the three methods of stent securement testing compared in the presentation?

    -The three methods compared in the presentation are: 1) The shim method, which uses stainless steel shims and an Instron tensile tester. 2) The tape method, which uses adhesive tape to secure the stent. 3) The MSI SR-1000 method, which utilizes segmental compression technology for more automated and controlled testing.

  • What are some of the challenges associated with the shim method?

    -Some challenges with the shim method include difficulties with sample alignment. If the sample isn't perfectly straight, axial angulation can result in higher stent securement forces that are not indicative of the actual securement. Additionally, different-sized shims are required for various stent and balloon sizes, adding complexity to the setup.

  • Why does the tape method yield the highest securement forces?

    -The tape method yields the highest securement forces because the tape often adheres to the balloon underneath the stent in addition to the stent itself. This adhesion increases the perceived securement forces, even though it may not accurately reflect the actual securement of the stent on the balloon.

  • What are the key advantages of the MSI SR-1000 over the other methods?

    -The key advantages of the MSI SR-1000 include a more automated setup that reduces operator variability, the ability to control both the diameter and force applied to the balloon, and a shorter setup time of around one to one and a half minutes per sample. It also provides more consistent and accurate data with lower standard deviation compared to the other methods.

  • How does the SR-1000 system ensure accurate stent securement testing?

    -The SR-1000 system ensures accuracy through its segmental compression technology, which grips the catheter and balloon with precise radial force. It controls both the diameter and the force applied to ensure consistent and linear alignment of the sample, eliminating side axial loading that can skew results. The system is also fully PC-controlled, minimizing operator error.

  • What were the findings regarding the standard deviation of the securement forces for each method?

    -The tape method had the highest standard deviation (0.36 pounds), indicating significant variability in the results. The shim method had a lower standard deviation (0.1 pounds), while the MSI SR-1000 had the smallest standard deviation (0.06 pounds), showing that it produced the most consistent and reliable results.

  • Why is the video system integrated into the SR-1000 system beneficial?

    -The video system integrated into the SR-1000 is beneficial because it allows operators to visually confirm the moment the stent starts to dislodge. This feature is linked to the data in real-time, ensuring accurate identification of the initial dislodgement point, which helps when analyzing forces and ensuring precise testing.

  • What conclusion was drawn about the commonly accepted minimum retention force of 0.5 to 1 pound?

    -The presentation concludes that the long-standing notion of a minimum retention force of 0.5 to 1 pound may be based on the tape method, which produces artificially high securement forces. This standard should not necessarily be applied to other methods, like the MSI SR-1000 or the shim method, which provide more accurate measures of stent securement.

Outlines

00:00

🎤 Introduction and Background

Melissa Lockwitzer introduces herself and her presentation on stent securement testing. She provides an overview of her background in biomedical engineering and her role at Machine Solutions, a leader in medical device manufacturing and testing. She also mentions her work with ASTM subcommittee fo4.30.06, which developed the standard for stent securement testing. The introduction highlights the importance of stent securement testing for patient safety and the need for compliance with FDA requirements.

05:01

🛠 Methods of Stent Securement Testing

Lockwitzer describes the three methods of stent securement testing: the shim method, tape method, and MSI's SR-1000 system. She explains how each method works, focusing on ease of setup, operation, and output variability. The shim method uses stainless steel shims and Instron tensile testers, while the tape method involves adhesive tape to secure the stent. MSI's SR-1000 is the most automated system, utilizing segmental compression technology for more precise and consistent testing.

10:02

📏 Shim and Tape Methods Explained

A detailed look at the shim and tape methods, including their challenges and setup processes. Lockwitzer explains the specifics of the shim method, which uses stainless steel shims and the ASTM guidance document f2394-07 for stent testing. She also highlights the difficulties with axial angulation in the setup, which can lead to higher stent securement forces. The tape method is discussed in detail, explaining the labor-intensive process of cutting and placing the tape precisely, the challenges in preventing tape adhesion to the balloon, and the use of standard Instron tensile testers to pull the stent.

15:03

🔧 The MSI SR-1000 System

Lockwitzer describes how the SR-1000 system from MSI works in comparison to the other methods. This fully integrated system uses motors, load cells, and software to automate the stent securement process. It allows for precise diameter and force control, making the process more consistent. She explains how the system measures withdrawal force and distance and highlights the advantages of the SR-1000, such as the built-in video system, which records the exact moment the stent moves, correlating it with force data.

📊 Test Results and Observations

A comparison of test results from the three stent securement methods shows that the tape method has the highest standard deviation, while the SR-1000 provides the lowest variability. The tape method yields higher retention forces, but these are attributed to the tape's adhesion to the balloon, which causes misleading results. Lockwitzer emphasizes the SR-1000's advantages, such as reduced setup time and greater consistency across samples, due to its automated process and integrated video system.

🔍 Analyzing the Results

Lockwitzer discusses the reasons behind the variability in the test results, noting that the tape method's high variability is due to inconsistent adhesion to the balloon. She also notes that the time-consuming nature of the tape method and the non-circular opening of the shim method contribute to higher forces and variability in those methods. She concludes that the SR-1000 system reduces operator variability and provides more accurate results due to its precise control of force and diameter.

🏆 Key Conclusions and SR-1000 Advantages

The presentation concludes with key findings, suggesting that long-standing industry standards for stent securement forces might be based on outdated methods like the tape method. Lockwitzer suggests that the SR-1000 system, with its lower variability and simpler setup, offers a more accurate and efficient way of testing stent securement. She emphasizes that MSI's SR-1000 eliminates operator variability, ensures linearity, and offers precise control, making it the preferred method for stent securement testing.

📹 Demonstration of SR-1000 System

Lockwitzer wraps up her presentation by offering a video demonstration of the SR-1000 system in action. The video showcases the system's precise control over grip force, diameter, and pull distance, illustrating the dislodgement of the stent and how the data is captured. She invites attendees to visit the booth for a live demonstration and encourages further questions about the system.

Mindmap

Keywords

💡Stent securement testing

Stent securement testing is the process used to evaluate the stability and attachment of a stent to its delivery system, ensuring that it remains secure during implantation. The video highlights its importance in ensuring the stent reaches the intended treatment site safely. Stent securement is critical for patient safety, as improper securement can lead to severe complications such as dislodgement, compression, or embolization.

💡Dislodgement

Dislodgement refers to the unintended movement of the stent away from its correct position on the delivery system. The video explains that dislodgement can occur in several ways, such as straight dislodgement, where the stent moves out of the marker bands, leading to complications in deployment. If a stent completely dislodges, it can result in severe outcomes like the need for open-heart surgery to retrieve the stent.

💡Shim method

The shim method is one of the traditional methods used to test stent securement by utilizing thin stainless steel shims to grip the stent. This method is discussed in the video as part of the comparison between different testing methods. While widely used, the shim method is described as time-consuming and prone to errors if the sample is not perfectly straight, leading to inaccurate securement force measurements.

💡Tape method

The tape method involves using adhesive tape to secure the stent and balloon catheter for testing. The video discusses how this method is basic but prone to errors, such as tape adhering to the balloon rather than just the stent, which can skew test results. Despite being the most time-consuming setup, it produced the highest force results, possibly due to unwanted adhesion between the tape and balloon.

💡SR-1000

The SR-1000 is a testing system developed by Machine Solutions Inc. (MSI) for automated stent securement testing. In the video, it is presented as a more modern and efficient alternative to traditional methods like the shim and tape methods. The SR-1000 features segmental compression heads and an integrated video system, offering more accurate and reliable results with less operator variability.

💡ASTM guidance

ASTM guidance refers to the set of standards provided by the American Society for Testing and Materials (ASTM) to guide the testing of medical devices, including stent securement. The video mentions ASTM subcommittee F04.30.06, which is responsible for writing the standards on stent securement. These guidelines are important for ensuring that tests follow a consistent, reliable procedure, like in the shim method, which is based on ASTM F2394-07.

💡Segmental compression technology

Segmental compression technology is the mechanism used by the SR-1000 system, where compression heads grip the stent radially to simulate real-world forces during stent deployment. This technology reduces operator error and variability compared to other methods. It allows for precise control over the diameter and force applied to the stent, contributing to the system's improved accuracy.

💡Initial dislodgement force

Initial dislodgement force is the force required to begin dislodging the stent from the delivery system. In the video, this metric is used to evaluate and compare the effectiveness of different stent securement testing methods. The SR-1000, for example, produces lower and more consistent dislodgement forces compared to the shim and tape methods, highlighting its accuracy in measuring securement.

💡Crimping

Crimping is the process of tightly securing a stent onto a balloon catheter by applying pressure. In the video, crimping is performed using the MSI SC775 system, which applies both heat and pressure to ensure a secure fit. Proper crimping is essential for accurate stent securement testing, as it ensures that the stent is properly attached before any tests are conducted.

💡Standard deviation

Standard deviation is a statistical measure used to quantify the variation in a set of data. In the video, it is used to compare the consistency of results from different stent securement testing methods. The SR-1000 system has the lowest standard deviation, indicating that it produces the most consistent results, whereas the tape method showed the highest variability.

Highlights

Introduction to stent securement testing and its importance for patient safety.

Melissa Lockwitzer presents her background in biomedical engineering and experience in medical device testing.

Machine Solutions (MSI) as the global leader in medical device manufacturing and testing equipment.

Stent securement testing is required by the FDA, but its main importance is ensuring the stent reaches its treatment site safely.

Three main failure modes of stents: straight dislodgement, stent compression/buckling, and complete dislodgement.

MSI conducted a comparison test of three methods of stent securement testing: shim method, tape method, and MSI's SR-1000.

MSI's SR-1000 is the most automated of the stent securement methods, offering precise control and ease of use.

Shim method involves thin stainless steel shims and an Instron tensile tester, with challenges around sample angulation.

Tape method, while widely used, involves adhesive tape and presents significant variability in results due to tape adhesion to the balloon.

MSI SR-1000 uses segmental compression technology to provide consistent radial gripping, resulting in lower variability and more accurate data.

Testing showed that the tape method had the largest standard deviation, while MSI's SR-1000 had the smallest.

The SR-1000’s design reduces operator variability through force and diameter control.

SR-1000 integrates a video system for real-time monitoring and data synchronization, allowing precise identification of initial dislodgement.

The study revealed that industry assumptions about securement forces may be based on outdated methods like the tape method.

MSI's SR-1000 offers the fastest setup time, taking only about one to one-and-a-half minutes per sample compared to six minutes for the tape method.

Transcripts

play00:07

welcome everyone

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i am melissa lockwitzer and today i'm

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presenting the ins and outs of stent

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securement testing

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thank you very much for coming and

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listening to this presentation

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so we'll start over with a bit of an

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overview

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so i'll give you some background on

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myself as well as machine solutions

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the importance of stem securement

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testing

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and then what we did

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to compare three different stent

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securement type methods to really kind

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of give you an overview of what sten

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securement is out there today as well as

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where msi plans to take it in the future

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so my background i have my master's in

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biomedical engineering and i've worked

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in the medical device industry for eight

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years

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still in the

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industry today

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manager of the contract testing lab at

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machine solutions as well as other

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responsibilities

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and i'm a member of the astm

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subcommittee the fo4.30.06

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this is a subcommittee that actually

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wrote the standard

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the guidance on stent securement

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and recently i led the development team

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for msi's current extend securement test

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system the sr-1000

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so a little bit about machine solutions

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we are the global leader in medical

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device manufacturing and testing

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equipment

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we have a wide range of products from

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stent crimping

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self-expanding stent loading

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angioplasty balloon pleating and folding

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device testing equipment the sr1000

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which i'll talk more about today

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so what's so important about stent

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securement testing

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one of the key things is the fda

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requires it um but but more important i

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think to me than that is it's it's

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important for patient safety um the

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purpose of the testing is to verify that

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you know the balloon expandable stent

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that's crimped on that delivery system

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makes it to the intended treatment site

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in a very functioning and safe way

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so what sten securement looks for

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there's a few failure modes

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three that we're looking at here

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one is a straight dislodgement

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so if you look at the image on top here

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basically this is when the stent moves

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outside of the proximal and distal

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marker bands those marker bands are what

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the physicians use to position that

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stent and if that scent moves outside of

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that window there's going to be an issue

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with

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complete deployment of that stent

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and if that happens the doctor's then

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going to have to take significantly more

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time to attempt to deploy that stent in

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a different manner

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another failure mode is stent

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compression or buckling

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and that's

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pictured here

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definitely wouldn't want that pressed up

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against my vessel wall

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it's something that will

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with those struts being perpendicular to

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the plane of the stent you're going to

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end up possibly with perforation into

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your vessel wall and definitely damage

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in a longer healing time for that

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procedure

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then the kind of worst case scenario is

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a complete dislodgement of the stent

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that stent fully comes off of your

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delivery system and embolizes into your

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system now you're potentially looking at

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open heart surgery to retrieve that

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stent um

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and definitely a significantly longer

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recovery time than what you're planning

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on

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so the comparison test what we did at

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msi was we conducted a test to compare

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three methods of stent securement

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testing the shim method the tape method

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and msi's sr1000

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the purpose was to look at the ease of

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method setup

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ease of operation as well as output

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variability

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the sr-1000 was launched last year by

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msi and is the most automated of the

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methods

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both the shim and tape method have been

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in use for many years within industry

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and are currently in use today as well

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so some images of the test methods

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shim and instron

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the shim sorry

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the shim method which utilizes the

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instron tensile tester this is a method

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that uses thin stainless steel shims

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and instrument

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standard grippers to withdraw the

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balloon from

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the stent the tape method

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it's as as basic as it sounds you see

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two pieces of adhesive tape uh generally

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painters type tape

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and they're used to secure to the stent

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and standard in strong grippers are used

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to grip your

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catheter as well as the tape and

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dislodge the tape and stent

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from the balloon

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then you have the msi sr 1000 this uses

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our segmental compression technology

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just in a little different way so we

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have two segmental compression heads one

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acts as the gripper so you get a nice

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radial grip on your

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catheter and the other one acts as the

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shim

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and then the two heads are separated by

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a motor to dislodge the stand

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i'll get into more detail here as well

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so some close-up images of the shim

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method

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this kind of

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this fixture is designed around the astm

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guidance document f2

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f2394-07

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and it is just a guidance document and

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the shim method is one of the

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methods that is just a possible

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test method within that

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so you have

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two 5000 stainless steel shims these

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have rounded v-notches

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and that's what contacts the

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circumference of the stent's proximal

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edge

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and you have to have different

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you have to have different size shims

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for all of your different size stents

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and bloom systems

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and

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um along with instant system to support

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the custom base

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and withdraw so

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some of the other challenges uh with

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this method set up

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so on this image you can see our balloon

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and stent are below and then our

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catheter is above and this is where our

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grips from the instrument come down

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if this sample isn't perfectly straight

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if it has any kind of axial angulation

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to it you're going to get higher

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stent securement forces

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that aren't actually related to the the

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stent being secure onto the balloon

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then you have the tape method

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uh this uses two pieces of adhesive tape

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a lot of times just a painters grade of

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tape

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a lot of

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effort is put into cutting the tape to

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the exact length of the stent

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so as you can see in this image

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my proximal edge of the stent ends right

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at the edge of the tape distal end right

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at the edge of the tape you can see it

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here as well

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this is the edge of my stent

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and then we create two tabs

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these two tabs are just folded over a

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piece of tape so we're actually grabbing

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onto the tabs and we want to prevent any

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of the tape from adhering to either the

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proximal or distal edge of the balloon

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we also use a clam shell fixture so we

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need to basically stick the tape to the

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stent without actually compressing it

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with our hands or in a non-circular

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fashion because we don't want to change

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how that stem stem's been crimped before

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we do our testing so

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we have multiple clam shells that are

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have radiuses sized to the stent plus

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the thickness of the tape

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so that we can place the tape in the

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clamshell the stent on top tape on top

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of that

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close the clam shell and try to secure

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the tape or secure the tape just to the

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stent and not to the balloon

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well um if the stent has been probably

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properly secured onto the balloon you

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have parts of that balloon that stick up

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and it's very hard to prevent um the

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stent or the tape from sticking to that

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balloon that's right underneath the

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stent itself

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we use a standard instron pencil tester

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with two standard grips to dislodge the

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stent and tape and hold on to the

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catheter

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significant patience was needed with

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this method it was the longest

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setup per device it took over six

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minutes to get everything set up just

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right um to be able to get as clean a

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data as we possibly could with this

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method

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segmental compression so msi's sr1000

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so with this method we have it's a fully

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contained system has the motors load

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cells

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and the software all incorporated into

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the system

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the segmental

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compression head that has one millimeter

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thick segments that acts as your shims

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and it has diameter and force control so

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you can close down that head to a set

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diameter

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as well as knowing exactly how much

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force you're applying to the balloon

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just distal to that stent

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the additional set of

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segments is used to grip and then we

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have a motor

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and load cell here that are used to

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separate those two and measure your

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withdrawal and force as well as the

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withdrawal distance

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another nice feature with the sr 1000 is

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the integrated a video system with the

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data

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sometimes if you can see on this graph

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your securement data is very obvious

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this is your initial dislodgement point

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but sometimes it's not quite as obvious

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and having that video linked in time

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allows you to see exactly when that

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stent started to move and compare that

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to where your data

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where the forces are at on your data

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test samples and preconditioning so we

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use 30 stainless steel balloon

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expandable stents

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just a standard 3.5 millimeter od by 24

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millimeter length

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we crimped them on to pleated and folded

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balloons

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using the msi sc775 this system allows

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us to crimp to a force while imparting

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heat and pressure into the balloon

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that pressure within the balloon

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while we're crimping down to force

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allows that balloon to kind of expand

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slightly underneath that stent and get

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into any of kind of the between struts

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um or between segments so that you get a

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very tight securement of that

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stent after we crimped the stents outer

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diameters were measured to make sure all

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30 samples um were identical before they

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were randomized into the three different

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groups we had a standard deviation of

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less than one thousandth of an inch

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for our final ods

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the samples were not tracked through a

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torturous path

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as the astm standard calls out they were

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soaked in a water bath we opted to not

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track them for this testing just that we

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could maintain as uniform as possible

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samples

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as soon as they get tracked there may

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have been slight

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differences in the stents and because we

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were just looking at comparing the three

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methods and not actually you know

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testing actual securement or

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wanting to submit this data we

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chose to not track the samples

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so the test parameters we tried to keep

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everything as similar as we could

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between the three methods one of those

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similarities was the pull rate so 10

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inch per minute this is based on the

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guidance document

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the shim size

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was

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36th out of 46 thou

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because they're slightly oval

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and non-circular that was the diameter

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range for those

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the sr-1000 capture diameter

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was one millimeter with a capture force

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of one newton plus or minus 0.2 so we

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actually can know what force we're

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applying on that balloon

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and the pull distance was set to 10

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millimeters for all of the methods

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so the results the exciting part here so

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there we go i got a smile

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we have 10 stents that were tested with

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each method the graph shows the

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initial dislodgement force in pounds

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the blue is the sr 1000 data the red is

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the shim data and the green is the tape

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method

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as you can

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really obviously see the tape method had

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the largest standard deviation

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0.36 pounds

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the shim method was a little tighter on

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the standard deviation 0.1

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msi was below 0.1 at 0.06 pounds

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but you also see along with the

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i guess large difference in standard

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deviations is the large difference in

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your actual state retention forces we're

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looking at an average of two pounds for

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the tape method

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0.5 pounds for the shim and about 0.25

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for the sr-1000

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so really wanting to look at

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what causes you know those

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dramatic differences i guess

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statistically difference uh

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statistically significant differences um

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in data

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so before we touch on that um just

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wanted to highlight how that initial

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dislodgement force was pulled from the

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data um it was actually fairly simple

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with this group of stents we just looked

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at the peak before

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a drop in force was shown

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so as you can see here this was actually

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a lateral move so we actually kept going

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up right here was our peak force before

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we saw a drop in force and so that would

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be our initial dislodgement force

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there can be higher forces

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farther along in the data and that may

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be from the stent going over a distal

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seal a marker band or other feature on

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the balloon that's meant to secure it

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that may cause higher forces

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so in comparing these three methods with

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this close to identical devices as

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possible it's a destructive test so you

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can't use the same sample over and over

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again

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the difference is definitely

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statistically significant

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the tape method yield the highest forces

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but that's most likely due to the tape's

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adhesion to the balloon beneath the

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stent as well as the stent itself no

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matter how much we try to gently

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compress that tape onto that stent you

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just can't avoid that that adhesion

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there

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as well as the variation in the tape

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adhesion to the balloon there might be a

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little more balloon sticking out on some

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stents than on others and as soon as

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different amounts of balloon are adhered

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to the tape you're going to have

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a great variation in actual your

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securement data

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the tape method was also the most time

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consuming if you compare the three

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methods the tape method took upward of

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six minutes per sample to set up the

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shim method was seated in about three

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minutes per sample to set up and the sr

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1000 was at a minute to a minute and a

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half to set up for each sample

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the non-circular opening of the rounded

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v-notches on the shim method

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really can be attributed to the slightly

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higher forces with that method

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not knowing exactly how much compression

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you're getting on that balloon and

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depending on the pleat and fold of that

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balloon

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as well as slight angulations in our

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setup definitely led to more variation

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and higher forces within that method

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so some key conclusions i guess from

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this data the long-standing notion that

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the minimum retention force of a half to

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one pound for a secured device

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may truly be based on the tape method

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and should not be applied to other

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methods of stent securement testing um

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for a long time when we looked at sense

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securement data and saw forces below a

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half a pound we're like oh that's you

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know not a very secure device but i

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think it just really depends on the

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method that you're using to secure that

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to test that securement

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the standard deviation within the tape

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as well as those misleading high values

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should really put this method into

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question and the sr-1000 produced very

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similar results to the the shim it had a

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simpler setup and you could use the same

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setup for a wide range of your diameters

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and the smaller standard deviation

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highlights its innovative qualities

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so some of the features that

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msi put in to the sr 1000 to

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eliminate some some of that variation

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we really wanted to eliminate operator

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setup variable thus putting in the

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diameter control as well as the force

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control

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the key with the two sets of segmental

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head it keeps those two heads concentric

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so when you close down on your grip and

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you close down on your capture that

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sample in there is always linear you're

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not going to have any other side axial

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loading to add variability to your data

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we have a very short gauge length that

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we can use on our system it prevents

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stretch effect of the catheter we're

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pulling a polymer

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if there's any stretch within that

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sample that's going to lead to some

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variation in your data

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and then also the system just being pc

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controlled all of the force and diameter

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calibrations are simply done within the

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system leads to a lot of

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eliminates a lot of operator variability

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the sr-1000

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it can be kind of a little harder for

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you guys to visualize you may not be as

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familiar with it

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the tape and shim are out there so i did

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want to show you a video today just to

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allow you to kind of see

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um

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oops sorry let me pop back

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there we go

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just so you can see how the sr-1000

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works we also have this system at our

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booth so if you want a live

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demonstration please stop by our booth

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so this is the

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the grip side of the segments closing

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down on your catheter shaft

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so we usually set this just to a grip of

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20 newtons just so we have a strong hold

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this is the one millimeter

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shim segment

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closing down to a set diameter or a set

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force

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now you can see the two segments

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this is your grip and this is your shim

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and now you can see the stent

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initial dislodgement as it pulls in

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within the software

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you have full control of your closed

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diameter closed speed your pull speed

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as well as your grip force

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and your pull distance in this study we

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did the 10 millimeter length pull

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the most interesting information

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generally does occur within this first

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one millimeter of the pull

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but sometimes it's you know just

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beneficial to see what's also happening

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as it's going over your distal seal or

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other features of your balloon as it

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gets withdrawn into your stent

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and so it's nice to have both this video

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and data are then linked in time

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so if your operator may have missed when

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that initial dislodgement happened they

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can go back and pull up that video and

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find that force

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that they need for their

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submittal

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so that's uh concludes my presentation

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today but if there's any questions i'd

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be happy to take them now or you can

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stop by our booth 3135 and i can take

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questions there as well

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thank you very much for your time and

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attention today

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you

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Stent TestingMedical DevicesPatient SafetyMSISR-1000Biomedical EngineeringFDA ComplianceStent SecurementTesting MethodsHealthcare Innovation
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