ViVitro Labs News

Crossing Profile

April 1st, 2021

Crossing Profile
A measurement of the maximum diameter over the length of the delivery system, from the proximal end of the mounted stent to the distal tip.

TEST PROCEDURE
With the stent pre-mounted or hand crimped on the delivery system in accordance with the instructions for use, and the sheath (if any) in place, measure the maximum diameter over the length from the proximal end of the mounted stent to the distal tip of the delivery system.

EQUIPMENT
The measurement instrument is a non-contacting calibrated optical system.

MEASURED PARAMETERS
Diameter of the length of the device.

SERVICE LEVELS
Fast Track
Standard Service
Full Service
APPLICABLE STANDARDS
ASTM F2081 – 06(2017)
Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

ISO 10555-5:2013
Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters

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

Stent System Compliance

April 1st, 2021

Strut and Bridge Thickness

April 1st, 2021

Percent Solid Area

April 1st, 2021

Dislodgment Force – Stent Securement

March 5th, 2021

Direct Longitudinal Compression

March 5th, 2021

Local Compression

March 5th, 2021

Crush Resistance – Parallel Plates

March 5th, 2021