Healthcare Industry News: ArthroCare
News Release - April 26, 2007
ArthroCare Receives FDA Clearance to Market Magnum(R) PI Knotless Implant SystemAll-PEEK Version of Magnum 2 Implant Provides Surgeons with Non-Metallic Option
AUSTIN, Texas--(HSMN NewsFeed)--ArthroCare® Corp. (Nasdaq:ARTC ) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market its Magnum PI Knotless Implant System, which utilizes implants made of polyetheretherketone (PEEK) for the attachment of soft tissue to bone.
"Receiving clearance from the FDA to market the Magnum PI is a great next step for our Opus® collection of products," said Jack Giroux, President of ArthroCare Sports Medicine. "ArthroCare is providing clinically proven tools orthopedic surgeons need to achieve fast, simple solutions to challenging fixation problems in the shoulder and elsewhere. We've now expanded the range of surgical options to include non-metallic, PEEK anchors. It's something that many of the surgeons have been asking for, and it's great to be able to deliver such an exciting and innovative product."
Giroux also said that the Magnum PI Knotless Implant System can be used in shoulder-related procedures such as rotator cuff repairs and in Achilles tendon repair in the foot, among several other indications. He explained that ArthroCare's knotless implant systems are designed to enable trained physicians to perform such surgeries faster and easier.
Founded in 1993, ArthroCare Corp. (www.ArthroCare.com) is a highly innovative, multi-business medical device company that develops, manufactures and markets minimally invasive surgical products. With these products, ArthroCare targets a multi-billion dollar market opportunity across several medical specialties, significantly improving existing surgical procedures and enabling new, minimally invasive procedures. Many of ArthroCare's products are based on its patented Coblation technology, which uses low-temperature radiofrequency energy to gently and precisely dissolve rather than burn soft tissue -- minimizing damage to healthy tissue. Used in more than four million surgeries worldwide, Coblation-based devices have been developed and marketed for sports medicine; spine/neurologic; ear, nose and throat (ENT); cosmetic; urologic and gynecologic procedures. ArthroCare also has added a number of novel technologies to its portfolio, including Opus Medical sports medicine, Parallax spine and Applied Therapeutics ENT products, to complement Coblation within key indications.
SAFE HARBOR STATEMENTS
Except for historical information, this press release includes forward-looking statements. These statements include, but are not limited to, the company's stated business outlook for fiscal 2007, continued strength of the company's fundamental position, the strength of the company's technology, the company's belief that strategic moves will enhance achievement of the company's long term potential, the potential and expected rate of growth of new businesses, continued success of product diversification efforts, and other statements that involve risks and uncertainties. These risks and uncertainties include, but are not limited to the uncertainty of success of the company's non-arthroscopic products, competitive risk, uncertainty of the success of strategic business alliances, uncertainty over reimbursement, need for governmental clearances or approvals before selling products, the uncertainty of protecting the company's patent position, and any changes in financial results from completion of year-end audit activities. These and other risks and uncertainties are detailed from time to time in the company's Securities and Exchange Commission filings, including ArthroCare's Form 10-K for the year ended Dec. 31, 2006. Forward-looking statements are indicated by words or phrases such as "anticipates," "estimates," "projects," "believes," "intends," "expects," and similar words and phrases. Actual results may differ materially from management expectations.
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