Withdrawbility involves retracting or re-sheathing the medical device as part of simulated use testing to determine the ability to withdraw.
Uses the Proximal load cell to measure the force to retract or re-sheath the device from a tortuous anatomy with or without the aid of a guiding accessory such as a guidewire, guide catheter, etc.
The system is retracted back to the starting point through the track model. During retraction, the IDTE 1000 proximal load cell is used to monitor the force applied at the proximal end of the device. At the same time, an encoder, attached to the proximal load cell, is used to monitor the travelled distance. 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.
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.
- Maximum, minimum and average force
- Location of maximum and minimum force
- Travel distance
- Proximal Force
- Distal Force
- 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
FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
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:
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.
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.