Simulated Use Testing Under Pulsatile Flow

Devices can be subjected to various physiological pulsatile flows and pressures.

Test Procedure

Our lab can control  cardiac flow and pressure experienced by a variety of endovascular medical devices and delivery systems. Anatomical models, including abnormalities or custom patient-specific models can be used. Ensure that devices can be delivered and deployed in a safe, consistent and accurate manner within the intended implant site and with intended use conditions.

Our lab team has used the Endovascular Simulator to perform tests including the following applications:

Equipment

Using the ViVitro Endovascular Simulator,  physiological pulsatile flows and pressures can be re-created to test many types of cardiovascular devices and any portion of the cardiovascular system. Our vascular flow platform brings physiological pulsatility to anatomical models.

Scope

Any cardiac device. Example tests include:

-Implantable pressure measurement verification
-Procedural planning
-Testing for contamination during bolus delivery of multi-lumen catheter under pulsatile flow

Service Levels

• Standard Service
• Full Service

Applicable Standards

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

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

Related Tests

• Simulated Use Testing
• Simulated Use Testing with Backout Support
• Simulated Use Pre-conditioning

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