Profile Effect / Flaring

Ensure the distal tip of crimped stent remains in contact with the balloon at all times, while navigating through a tortuous path. The degree of flaring of the stent away from the balloon is measured.

Test Procedure

Uses a contactless optical measurement system to measure the outside diameter of the stent and the outside diameter of the balloon, in a bent configuration. The measured gap between these measurements is the amount of flaring.

Equipment

Contactless optical measurement system

Calibrated gauge blocks

Catheter support fixture

Service Levels

Applicable Standards

ISO 25539-2:2020
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
FDA-1545
FDA Guidance: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems – Guidance for Industry and FDA Staff

Related Tests

OLE1209

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