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 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)
ViVitro uses the Interventional Device Testing Equipment (IDTE)1000 to comparatively and quantitatively tests and records the performance features of interventional devices
All Cardiovascular devices undergoing Verification and Validation testing (V&V) testing
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
FDA Guidance: Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters – Class II Special Controls Guidance for Industry and FDA
- Acute Particulate Matter Evaluation
- Pulsatile Flow Testing – Hydrodynamic Performance
- Radial Fatigue and Pulsatile Durability
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.
Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.
We happily provide Non-Disclosure Agreements for all services, including initial consultation.