Stent Securement – Dislodgement Force

Stent Securement – Dislodgement Force: Measured parameters

• Force required to completely dislodge the stent from the delivery system balloon
• Stent securement force

Stent Securement – Dislodgement Force: Scope

• Stent
• Balloon expandable stent
• Any balloon mounted devices

Stent Securement – Dislodgement Force: Applicable standards

• ISO 25539-2 – CARDIOVASCULAR IMPLANTS – ENDOVASCULAR DEVICES – PART 2: VASCULAR STENTS
• FDA GUIDELINES – GUIDANCE FOR INDUSTRY AND FDA STAFF NON-CLINICAL ENGINEERING TESTS AND RECOMMENDED LABELING FOR INTRAVASCULAR STENTS AND ASSOCIATED DELIVERY SYSTEMS
• GLP STUDIES PER CODE OF FEDERAL REGULATIONS CFR21, PART 58 – GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES (APRIL 2010)
• ASTM F2394-07 MEASURING SECUREMENT OF BALLOON EXPANDABLE VASCULAR STENT MOUNTED ON DELIVERY SYSTEM

Stent Securement – Dislodgement Force: Related testing

• Simulated use – Device pre-conditioning
• Radial force (displacement control), Crush resistance (Pressure control)
• Recoil and Foreshortening

*SR 1000 Images courtesy of Machine Solutions Inc

Stent Securement – Dislodgement Force: Test Method Description

Measure and record forces required to dislodge a balloon-expandable stent from its delivery system under clinically relevant conditions.

Forward Motion Dislodgement (Lesion-type test) : Advancing a stent delivery system across a tight lesion could result in stent dislodgement.

Reverse Motion Dislodgement (Guide-type test) : Withdrawing a stent (un-deployed) delivery system into a guiding catheter, arterial sheath, or hemostasis valve could result in stent dislodgement.

Worst case stent securement configuration is used for this test.