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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 25-Mar-10 BY LAUREN UZDIENSKI, MARCH 25, 2010

Earnings
Rhausler, Inc., a spine company marketing the Rhausler Dynamic and Semiconstrained Anterior Cervical Vertebrae Plating System, announced that 2009 revenue increased 700% over the prior year.

Regulatory
Bovie Medical received FDA clearance for the BOSS bipolar device, which uses RF energy with saline to cause coagulation of soft tissue and bone. The company says use of the device can result in "reduced blood loss while minimizing charring and sticking of tissue." The company will primarily target surgeons performing hip and knee arthroplasties.

Custom Spine received FDA clearance for the PATHWAY ACIF, an anterior cervical interbody spacer that the company says "complements their low-profile anterior cervical plate system," the Regent ACP. PATHWAY ACIF is made from PEEK-OPTIMA and is available in both parallel and lordotic profiles.

An FDA panel found that ReGen's Menaflex collagen meniscus implant was "likely safe" despite certain shortcomings in their clinical data, including study design, missing data and potential bias. The agency will now determine whether to do nothing, initiate special controls or up-classify the device. The latter options may require additional data collection or a new marketing application.

Stryker announced that one of its three outstanding FDA warning letters has been resolved. The FDA concluded that actions taken to correct deficiencies at the company's Mahweh, NJ manufacturing site were sufficient and no further corrective actions were required.

Product Introduction and Update
Aesculap Implant Systems launched the Spyder Minimally Invasive Spinal Retractor System, which is indicated for use in the lumbar spine with Aesculap Spine's S4 Pedicle Screw System. The system features top-loading blades that can be removed intra-operatively without removing the retractor frame and is made from an X-ray-translucent titanium alloy.

Axis Surgical Technologies announced that their C-MOR Visualization Device has been used for the first time in a spine procedure. The company describes the C-MOR as a self-contained direct-imaging tool that is smaller and more economical than a standard arthroscopic tower.

Legal
CareFusion, who recently launched a kyphoplasty balloon, filed a claim against Medtronic in federal court. CareFusion alleges that Medtronic violated antitrust laws and asserted invalid patents with the intention of preventing CareFusion from bringing their products to market.

Reimbursement
RTI Biologics introduced a toll-free hotline to field reimbursement questions from physicians and hospitals. The company will also respond to questions submitted over the internet.

In response to a NASS survey, 24% of spine physicians participating in Medicare said they may withdraw from the program if scheduled payment reductions occur later this year.

Distribution
CONMED Linvatec, Smith & Nephew and Stryker have signed agreements to supply arthroscopy devices to Premier Purchasing Partners. Premier's network includes more than 2,300 U.S. hospitals and 66,000 other healthcare sites.

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