Extremities

FDA Questions First PMA for Synthetic Cartilage Implant Ahead of Advisory Panel

Posted 18 April 2016 By Zachary Brennan

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Monday raised key questions about the effectiveness of Cartiva’s first-of-its-kind synthetic cartilage implant, which is intended to treat osteoarthritis pain in the first joint of the big toe.

The implant, which is made of an organic polymer-based biomaterial comprised of polyvinyl alcohol and saline, is designed to work in a manner similar to how biologic cartilage works, but it’s intended to help with damaged cartilage and to allow for pain reduction and maintained range of motion.

The Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee, a panel of outside experts, will listen to both Cartiva and FDA officials explain what they saw in the company’s clinical trial of the implant at a meeting Wednesday.

 

READ THE REST HERE

Print Friendly, PDF & Email
Tags

Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

Related Articles

Leave a Reply

Your email address will not be published. Required fields are marked *

Back to top button