Dislodgment Force – Stent Securement

Force required to initiate stent displacement from its initial crimped position and to completely dislodge the stent from the delivery system.

 

Test Procedure

Shim plate method. The IDTE-1000 is used to measure the force required to dislodge the pre-mounted stent from the crimped position on the non-expanded balloon and to completely separate the stent from the non-expanded balloon.  The sample is advanced into a specific sample retainer fixture, made of two plates forming a hole with a specific diameter. The IDTE roller system is used to grab the catheter with a constant grip force. The catheter is pushed or pulled through the stent retainer system until the minimum dislodgement force is recorded. Stent Behaviour is recorded with a video camera.

Pre-conditioning can be done by passing the system through a tortuous anatomy before the test.

Equipment

-IDTE-1000

-Stent Sample retainer fixture

 

 

Measured Parameters

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.

Scope

  • Stent
  • Balloon expandable stent
  • Any balloon mounted devices

Service Levels

Applicable Standards

  • ISO 25539-2:2020
    Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

  • ASTM F2394-07
    Standard Guide For Measuring Securement Of Balloon Expandable Vascular Stent Mounted On Delivery System

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