Simulated Use Testing with Backout Support

A Catheter is deployed over a guidewire. The Catheter is removed and guidewire must be left in place. Special case of Simulated use testing.

Test Procedure

The goal is to measure the ability of the guide wire to remain in position in the tortuous path during stent system advancement. The guide wire is advanced through the tortuous path to the end location. The stent system is then advanced over the guide wire, free of movement, while measuring the force to advance the stent system and monitoring the movement of the guide wire with a video system.

Equipment

ViVitro uses the Interventional Device Testing Equipment (IDTE) 1000 to provide quantitative performance evaluation of interventional devices during simulated use testing. This test is conducted by advancing a device in a pre-defined anatomical vascular model to simulate the passage of devices during interventional procedures. Standard or specific anatomical 2D and 3D models can be used to simulate device insertion, tracking, deployment and retrieval.

The device is advanced and retracted automatically by the roller system which removes bias due to operator interactions.  The IDTE proximal roller system measures advancement forces along the path and the auxillary load cells can be placed in various locations to measure distal forces on the device or resulting forces on interventional accessories.  The IDTE roller system can handle infinite length catheter and a continuous advancement of the device during testing. No repositioning of the head is necessary.  The IDTE equipment is PC controlled with numerous options for advancement profiles. Testing results can be used for regulatory submissions, competitive product evaluation and product development.

Measured Parameters

  • Maximum, minimum and average force
  • Location of maximum and minimum force
  • Temperature
  • Travel distance
  • Proximal Force
  • Distal Force

Scope

  • PTA, PTCA, coronary and peripheral stent delivery systems – functional performance during simulated use
  • TAVI and TMVR delivery systems – functional performance during simulated use
  • Thrombectomy devices — functional performance during simulated use
  • Guidewires testing – functional performance during simulated use
  • Endoscopic devices – functional performance during simulated use
  • RF ablation catheters testing – functional performance during simulated use
  • Any interventional delivery systems – functional performance during simulated use

Service Levels

Applicable Standards

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

  • ISO 5840-3:2021
    Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques

  • ISO 5910:2018
    Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices

  • FDA-1608
    FDA Guidance: Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters – Class II Special Controls Guidance for Industry and FDA

  • 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

OLE/QV

IDTE 1000

ViVitro Labs Advantages

Many companies look to academia to handle their testing needs due to the reduced cost. With ViVitro Laboratory Services you gain the following advantages:

Time to Market
We understand how critical your timelines are. Our expertise and experience ensure your schedule is met and our commitments are delivered on time.

ISO 17025 Accredited
For studies used for regulatory approval this is a must. Accredited by A2LA and Cofrac.

Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.

Guaranteed Confidentiality
We happily provide Non-Disclosure Agreements for all services, including initial consultation.

Join over 5000 cardiovascular device professionals who receive our testing and engineering insights and tips every month.