Additional Testing Services

Description

MSI provides testing services on a contract basis at our testing lab in Flagstaff, AZ. In addition to the IDTE, RX, and SR testing equipment which MSI has developed, we can complete additional tests which may be required for device evaluation and regulatory submission.

Applicable standards Include:

  • ISO Standard 25539-2:2008(E) Cardiovascular Implants- Endovascular Device
  • Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems – Guidance for Industry and FDA Staff – 2005
  • ASTM F2394-07 for preconditioning of the stent on the deployment system prior to retention testing

Contact us about testing services

Standard Test Protocols include: 

  • Balloon burst
  • Insertion force measurement
  • Balloon fatigue
  • Lesion crossability force
  • Bifurcation “kissing” stent force
  • Push efficiency
  • Catheter-guidewire compatibility
  • Stent Flexibility
  • Catheter component tensile
  • System burst strength
  • Tip pull
  • Catheter profile
  • Torque strength
  • Compliance
  • Torqueability
  • Crossing profile
  • Track force
  • Flex (kink)
  • Vessel straightening forces
  • Individual bond strength
  • Inflation/deflation time

 

Video & Images

MSI Catheter Testing Equipment

Spec. Sheet Download

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