Healthcare Industry News: cardiac monitor
News Release - August 14, 2008
CONMED Linvatec's Bio Mini-Revo(TM) Suture Anchor Receives 510(k) FDA Clearance for Arthroscopic Hip RepairUTICA, N.Y.--(HSMN NewsFeed)--CONMED Corporation’s (Nasdaq: CNMD ) CONMED Linvatec arthroscopy unit announced today that the U.S. Food and Drug Administration (FDA) has cleared its 510(k) application for marketing of the Bio Mini-Revo™ suture anchor for use in the repair of the labrum in the hip joint. The Company recently executed a full market launch for this product.
The hip labrum is a form of cartilage that lines the rim of the socket of the hip. Torn and detached labral tissue is associated with hip pain during movement. In an arthroscopic technique, surgeons use suture anchors to reattach the torn cartilage to the rim of the socket to relieve pain and regain normal hip function.
The Bio Mini-Revo™ anchor is a bioabsorbable 3.1mm diameter screw-in anchor manufactured from CONMED Linvatec’s patented Self Reinforced 96L/4D Poly Lactic Acid. This unique material provides an optimal balance of strength (during the initial healing period post-surgery) with enhanced resorption over time, negating the need for a second surgery to remove the implant. The anchor is pre-threaded with #2 Hi-Fi® high strength suture. Currently, there are no other suture anchors indicated for hip labral repair that contain the unique blend of mechanical strength and biomaterial characteristics of the Bio Mini-Revo™ anchor.
“Bio Mini-Revo™, and the associated extended length drill guides, provides the surgeon with a safe and effective method to repair the labrum,” said Dr. Christopher Dougherty, of The Agility Center, Bentonville, AR. “The Bio Mini-Revo™ technique and extended length instrumentation greatly aid in hip access and minimize the risks of failed anchor fixation."
“As hip arthroscopy continues to develop as a surgical specialty, and labral repairs in particular become more prevalent, we anticipate that the Bio Mini-Revo™ suture anchor will become an important part of our continuously expanding hip product line,” commented Mr. Joseph J. Corasanti, President and Chief Executive Officer. “We are excited that this safe and effective implant, which has already been used successfully in thousands of surgeries in the shoulder, will now be available to our customers for use in the hip.”
The Bio Mini-Revo™ anchor joins a growing number of products in the ConMed Linvatec Hip Arthroscopy line; including disposable hip access kits, cannulas, Shutt brand manual instruments, microfracture awls, shaver blades and burrs, and imaging and pump systems.
CONMED is a medical technology company with an emphasis on surgical devices and equipment for minimally invasive procedures and monitoring. The Company’s products serve the clinical areas of arthroscopy, powered surgical instruments, electrosurgery, cardiac monitoring disposables, endosurgery and endoscopic technologies. They are used by surgeons and physicians in a variety of specialties including orthopedics, general surgery, gynecology, neurosurgery, and gastroenterology. Headquartered in Utica, New York, the Company’s 3,200 employees distribute its products worldwide from several manufacturing locations.
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