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All ISO 10993 Thrombo Study Designs Are Not Created Equal

July 26, 2013

The in-vivo thrombogenicity assay is a widely used method for screening the ability of blood contacting medical devices to cause a clot upon implantation. The in-vivo thrombogenicity assay is designed to evaluate the thrombogenicity potential of a medical device in comparison to a predicate device already on the market. As medical devices continue to become more advanced, the clinical relevance and overall placement of the device begins to challenge the traditional methods.

American Preclinical Services (APS) offers a wide variety of thrombogenicity studies that can be custom tailored to your device. We have an array of fluoroscopic imagery and technical expertise that can address all of the concerns and issues associated with the traditional thrombogenicity design. When your device is in need of preclinical testing, consider the vast technical expertise APS employs within a single campus that will work in collaboration with you to incorporate study designs that are more relevant to the clinical application of your device. Our in-house expertise can reduce the number of tests and devices required for your preclinical submission. Give us a call today and see the difference.

Jugular vein and Balloon catheter

Jugular vein and Balloon catheter

 

EP Catheter and Jugular Vein

EP Catheter and Jugular Vein

APS is committed to providing you with Best-in-Class customer service for all your medical device testing requirements. Please contact Kent Grove or Michael Conforti today at 763-717-7990 to discuss your preclinical program needs.

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