Crossability

Uses the proximal load cell to measure the ability of the device to advance and withdraw, with no loss of function or damage to the tortuous anatomy, over a specific lesion site. The roller system and the camera allow determining the worst-case lesion that the stent can withstand without damage.

Test Procedure

A stenosis lesion site is modeled using successive tubes with decreasing diameters at the end of the path. The device is advanced in the defined path until the modeled lesion site is reached.  The IDTE 1000 proximal load cell is used to monitor the force applied at the proximal end of the device system. At the same time, an encoder, attached to the proximal load cell, is used to monitor the travelled distance. The sample is advanced through the tortuous path according to the specific profile. Proximal forces, as well as the advancement distance, are recorded simultaneously. The test fluid is circulated inside the anatomical model at a regulated at test temperature ±2°C. The devices are inspected visually, and any damage is recorded. A video camera could be used to record the device behavior through the lesion site

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

• Fast Track
• Standard Service
• Full Service

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

Related Tests

• Pushability
• Trackability
• Withdrawbility
• Simulated Use Testing
• Simulated Use Testing with Backout Support

OLE1220