CONFIDENTIAL Agenda ! A Brief History of Stent Durability Testing - - PowerPoint PPT Presentation

▶

Mar 09, 2024 286 likes •564 views

Recent Advances in Test Bench Solutions for DES and Bio- Degradable Stents Lito Mejia, David Dingmann, Jacques Laudinet Bose Corporation 7 th European Symposium of Vascular Biomaterials ESVB 2011, May 13-14 Strassbourg, France CONFIDENTIAL

SLIDE 1

CONFIDENTIAL

Recent Advances in Test Bench Solutions for DES and Bio- Degradable Stents

Lito Mejia, David Dingmann, Jacques Laudinet Bose Corporation

7th European Symposium of Vascular Biomaterials ESVB 2011, May 13-14 Strassbourg, France

SLIDE 2

CONFIDENTIAL

Agenda

! A Brief History of Stent Durability Testing by Bose
! Evolution: Multi-mode testing
! DES :specialized testing with particle characterization
! Validation Test data

SLIDE 3

CONFIDENTIAL

A Brief History

SGT’s first introduced commercially in 1995

SLIDE 4

CONFIDENTIAL

A Brief History

Multi-specimen testing Generation of S/N curves

SLIDE 5

CONFIDENTIAL

A Brief History

Multi-Mode Testing:

Extension / Contraction Torsion Compression Flexion + Pulsatile Distention

Peripheral Coronary

SLIDE 6

CONFIDENTIAL

Then came!.

! Coated Stents, Drug Eluting Stents, Biodegrable!

SLIDE 7

CONFIDENTIAL

Coating Durability – The Test

SLIDE 8

CONFIDENTIAL

Coating Integrity– Bench Testing

FDA Guidance Draft:

“The acute and chronic integrity of coating on the stent substrate should be assessed to provide reasonable assurance that the coating is able to sustain its integrity according to its design specifications. “

“The Agency requests that the sponsor qualitatively and quantitatively determine whether subjecting a DES system to expansion, deployment, and repetitive cycling modalities as experienced in the clinical setting will influence the ability of the coating to interact appropriately with the stent substrate.” Today’s Chronic Durability Assumptions:

Minimum 9 month fatigue test (30,000,000 cycles)

Worst Case 10 year pulsatile fatigue test (400,000,000 cycles)

Pulse on a 15 mm radius bend (Static Bend)

Overlapped stents (Static Bend)

Future?

repetitive cycling modalities as experienced in the clinical setting

SLIDE 9

CONFIDENTIAL

ElectroForce 9210-12 DES SGT

Design considerations:

Consistent distension

Performance > 9110 SGT

Elevated temperature capability

Minimize opportunities for trapped particulate

Minimal flow path length

Isolated flow paths –

No metal in the filtered test section of the flow loop

Active computer control & DAQ of:

–! Diameter controlled distension –! Pressure controlled distension –! Flow & temperature –! DAQ of individual tube flow –! Capture filter status & switching –! All system limits and actuations

Integrate Laser Micrometer w/control software

Diameters: 2-14 mm

Lengths: up to 200 mm Accelerated Pulsatile Fatigue Test Frame

SLIDE 10

CONFIDENTIAL

ElectroForce 9210-12 DES SGT

(3) Test Configurations

Removable Filter Cartridges

Particle Counting Module Particle Capture Module Accelerated Pulsatile Fatigue Test Frame

SLIDE 11

CONFIDENTIAL

Isolate the stents from the PowerHeads : Dual PowerHeads:

Innovations in Technology

SLIDE 12

CONFIDENTIAL

Isolate the Flow over Stents !

Inlet from bellows Diaphragm Sample Tube Bleed port and sample installation Bleed port Mean flow port – to counting or capture

SLIDE 13

CONFIDENTIAL

Flow Loop synoptic

Sample Flow Loop

Upper Pulsatile Source Lower Pulsatile Source

SLIDE 14

CONFIDENTIAL

Flow tubes

SLIDE 15

CONFIDENTIAL

Uniform Distension: design rules

Diagram showing (2) PowerHeads (#110 & #112) providing (2) sided pulsatile distension to a row of mock arteries (#102)

SLIDE 16

CONFIDENTIAL

Performance

SLIDE 17

CONFIDENTIAL

Uniform distension: Tube to Tube

Benefits:

! Based on Proven Bose SGT

Technologies

Bose proprietary manifolds ensure each tube distends equally (#1 = #6 = #12)

! Multiple Tubes (12) Lower cost/stent

capital equipment

FDA requires minimum of (1) control tube for each machine.

This gives (11) useful tubes/test

! 37 C
! Controlled Flow

SLIDE 18

CONFIDENTIAL

Stent Deployment Ports

Innovations in Technology

Ability to connect a Tortuous Path for transition of Acute Test to Chronic Test for the same samples

SLIDE 19

CONFIDENTIAL

Validation Tests

To validate LO (Light Obscuration) Methodology:

! Bolus Testing per USP 788
! Particle Capture
! Sample versus Blank Tests

SLIDE 20

CONFIDENTIAL

Validation Tests: Bolus Testing

The chart shows actual LO results as provided by the instrument

SLIDE 21

CONFIDENTIAL

Validation of LO Particle Counting

SLIDE 22

CONFIDENTIAL

Validation Tests: Particle Capture

SLIDE 23

CONFIDENTIAL

Filters can be switched based

n various criteria or “Triggers”.
!

Triggers set by the user:

! Cycle count
! Time
! Flow rate
! Total flow through filter
!

The system will track these and divert flow to a new filter

The user will be alerted when a filter is full

Particle Characterization Module (PCM)

SLIDE 24

CONFIDENTIAL

Bolus Testing:Capture confirmation

Spheres captured by the filters from the bolus tests.

SLIDE 25

CONFIDENTIAL

Sample Test

Test Protocol:

! Clean & Flush System – 3-4 day process
! 37C Saline
! 160/80 mm Hg @ 1.2 Hz for 14 days
! Physiological U-tubes (very thin)
! 15 mm radius
! (2) Stents deployed in overlapped condition
! Counting via LO (laser) inline counters

SLIDE 26

CONFIDENTIAL

Sample device Test

Specimen setup, deployment ports and representative particle counting as a function of time.

SLIDE 27

CONFIDENTIAL

Recent Advances in Test Bench Solutions for DES and Bio- Degradable Stents

7th European Symposium of Vascular Biomaterials ESVB 2011, May 13-14 Strassbourg, France

Agenda

A Brief History

SGT’s first introduced commercially in 1995

A Brief History

Multi-specimen testing Generation of S/N curves

A Brief History

Multi-Mode Testing:

Peripheral Coronary

Then came!.

Coating Durability – The Test

Coating Integrity– Bench Testing

FDA Guidance Draft:

“The acute and chronic integrity of coating on the stent substrate should be assessed to provide reasonable assurance that the coating is able to sustain its integrity according to its design specifications. “

Minimum 9 month fatigue test (30,000,000 cycles)

Worst Case 10 year pulsatile fatigue test (400,000,000 cycles)

Pulse on a 15 mm radius bend (Static Bend)

Overlapped stents (Static Bend)

Future?

repetitive cycling modalities as experienced in the clinical setting

ElectroForce 9210-12 DES SGT

Design considerations:

ElectroForce 9210-12 DES SGT

(3) Test Configurations

Isolate the stents from the PowerHeads : Dual PowerHeads:

Innovations in Technology

Isolate the Flow over Stents !

Inlet from bellows Diaphragm Sample Tube Bleed port and sample installation Bleed port Mean flow port – to counting or capture

Flow Loop synoptic

Sample Flow Loop

Flow tubes

Uniform Distension: design rules

Performance

Uniform distension: Tube to Tube

Benefits:

Stent Deployment Ports

Innovations in Technology

Ability to connect a Tortuous Path for transition of Acute Test to Chronic Test for the same samples

Validation Tests

To validate LO (Light Obscuration) Methodology:

Validation Tests: Bolus Testing

Validation of LO Particle Counting

Validation Tests: Particle Capture

Filters can be switched based

Triggers set by the user:

The system will track these and divert flow to a new filter

The user will be alerted when a filter is full

Particle Characterization Module (PCM)

Bolus Testing:Capture confirmation

Spheres captured by the filters from the bolus tests.

Sample Test

Test Protocol:

Sample device Test

THANK YOU

Questions?