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

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

OLE1325


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.

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