- Force required to completely dislodge the stent from the delivery system balloon
- Stent securement force
Stent Securement – Dislodgement Force: Scope
- 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
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.