Cayenne Medical Receives FDA Approval For IFix(TM) PEEK Interference Screw System

Main Category: Bones / Orthopedics
Also Included In: Regulatory Affairs / Drug Approvals;  Sports Medicine / Fitness
Article Date: 28 Feb 2008 - 1:00 PDT

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Cayenne Medical, Inc., a privately held sports medicine company based in Scottsdale, announced that it has received market clearance from the U.S. Food and Drug Administration (FDA) for its iFix™ Interference Screw System for use in bone-tendon-bone ACL reconstruction procedures.

The iFix Interference Screws are the first FDA approved screws on the market that are manufactured using polyetheretherketone (PEEK™), a form of plastic which is highly biocompatible, biomechanically strong, and radiolucent.

The iFix system was developed to provide surgeons with a screw that has a superior biomechanical strength compared to bioabsorbable and biocomposite interference screws, and one that is superior to metallic screws which interfere with post-op imaging. Furthermore, the iFix Interference Screw has a uniquely designed tip and does not require tapping prior to insertion.

Some patients have foreign body reactions (inflammatory responses) common to traditional bioabsorbable and biocomposite screw materials. The iFix screws overcome this problem because PEEK is a totally bio-inert material.

"The FDA market clearance for our iFix screws is a key milestone for our company," said James W. Hart, President and CEO of Cayenne. "We have been known as a company that provides ACL reconstruction technology to surgeons utilizing the hamstring tendon technique. Now we can also provide something unique to those surgeons who practice the 'bone-tendon-bone' technique."

Hart added that to help further expedite procedural times, Cayenne will also offer a disposable procedural kit to accompany the iFix Interference Screws.

Last year, Cayenne received FDA approval for its platform AperFix™ System for soft tissue ACL reconstruction. In a revolutionary surgical procedure, AperFix provides active aperture compression and fixation with strong, rigid femoral and tibial implants, also made of PEEK. Cayenne's inserter handles facilitate rapid delivery of strong, rigid implants while simultaneously tensioning the graft to reduce laxity. For surgeons, AperFix provides a complete yet simple solution for consistent, replicable results utilizing the hamstring and other soft tissue grafts. Now with the arrival of iFix, Cayenne offers products to a broader range of surgeons performing knee ACL reconstruction.

About Cayenne Medical, Inc.

Based in Scottsdale, Arizona, Cayenne Medical is a privately held medical device company defining new technology for the soft tissue reconstruction segment of the sports medicine market. The company was founded in 2005 and is focused on leading the transformation of traditional ACL repair procedures by applying advanced technology through minimally invasive techniques.

http://www.cayennemedical.com

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