Simulated Use Pre-conditioning

Before conducting other evaluations, test samples should undergo all the steps a finished device would go through before being implanted in the patient.

Test Procedure

Test articles shall represent, as closely as possible, the finished system to be supplied for clinical use. This includes:

Exposure to the maximum number of allowed sterilization cycles (Done by client)
Process chemicals (Done by client)
Aging effects (Can be done by ViVitro Partner Organization)
Shipping/handling (Likely done by client when shipping samples to ViVitro)
Any loading and deployment steps (Done by ViVitro)
- Crimping or loading the implant into/onto a delivery catheter
- Tracking through simulated delivery pathways
- Implant shall be maintained in the crimped configuration for a duration that mimics the worst-case expected clinical procedure time
- Retrieval and repositioning (if applicable)

Equipment

ViVitro uses the Interventional Device Testing Equipment (IDTE)1000 to comparatively and quantitatively tests and records the performance features of interventional devices

Tortuous path

Measured Parameters

Speed rate

Distance

Scope

All Cardiovascular devices undergoing Verification and Validation testing (V&V) testing

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:

ISO 17025 Accredited
For studies used for regulatory approval this is a must. Victoria and Marseille labs accredited by A2LA.

Test Method Validation
The FDA and Notified Bodies around the world are requiring evidence of Test Method Validation. ViVitro Labs has invested significant resources to validate the most common test methods that are not ISO 17025 accredited. We continue to work closely with device manufacturers and share the burden with our clients to validate other specific test methods that are less in demand.

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

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.