Surgical products maker ArthroCare Corp (ARTC) has won the U.S. Food and Drug Administration’s (“FDA”) approval for its Spartan 6.5 needled anchor. The device, essentially a preloaded threaded anchor, has been designed for use in fixation of soft tissue to bone (such as rotator cuff surgery).
Rotator cuff repair is a surgery to fix a torn tendon in the shoulder. The procedure can be performed with a large (open) incision or with shoulder arthroscopy, which uses small incisions. The goal of the surgery is to attach the torn tendon back to the bone. More than 400,000 people undergo rotator cuff repair in the U.S. annually.
The newly approved needled version of the Spartan device is used for open repairs, while the previously-approved non-needled version is utilized for arthroscopic repairs.
The Spartan device, which is made from polyether-etherketone (a widely used material in orthopedic implants), complements the company’s existing range of anchors used with the FirstPass suture passer, its suture passing technology. The device can be used to perform single and double row repairs.
Austin-based ArthroCare develops and markets minimally-invasive, state-of-the-art surgical products, addressing a multi-billion dollar market opportunity across several medical specialties. Many of the company’s products leverage its proprietary Coblation technology, which uses low-temperature radiofrequency energy to dissolve soft tissue (instead of burning it), thereby minimizing damage to healthy tissue.
ArthroCare markets its Coblation-based products through three business units, namely, Sports Medicine, ENT and Spine. The company competes with Stryker Corp. (SYK), Smith & Nephew plc (SNN) and Johnson & Johnson (JNJ), among others.
ArthroCare secured the FDA approval, in February 2011, for its Parallax Contour enhanced vertebral augmentation device, designed for vertebral body void (or space) creation followed by injection of bone cement. Moreover, the company received FDA clearance for its Spartan 5.5 needled anchor.
The company, in May 2011, posted mixed first quarter results with earnings per share of 36 cents outpacing the Zacks Consensus Estimate of 29 cents while surpassing the year-ago earnings of 24 cents.
However, revenues fell 1.3% year over year to $87.9 million, missing the Zacks Consensus Estimate of $89 million, impacted by lower sales from the core Sports Medicine business. Separately, ArthroCare noted that it will consolidate the operations in its Sunnyvale, California facility with those in its headquarters in Austin, Texas, before end-2011. The move is expected to cost the company between $10 million and $10.5 million.
ARTHROCARE CORP (ARTC): Free Stock Analysis Report
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SMITH & NEPHEW (SNN): Free Stock Analysis Report
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