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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 4-Jun-2009 BY LAUREN UZDIENSKI, JUNE 4, 2009

Funding
Active Implants raised $10.0 million in a Series C preferred stock offering. The company is developing the TriboFit Hip and NUsurface implant systems based on its polycarbonate urethane technology. In conjunction with the financing round, the company appointed Charles E. Martin to its Board of Directors.

Regulatory
The FDA has created a transparency task force that may make product data more available to the public. Traditionally, much of the FDA's information on a product, including clinical trials data, was kept confidential to protect trade secrets. The task force will be led by FDA deputy commissioner Joshua Sharfstein, who will produce a report for commissioner Margaret Hamburg in six months.

Disc Dynamics received expanded CE Mark clearance for its DASCOR Disc Arthroplasty System. The system has been approved for use with a posterior-lateral approach and an endoscopic approach. The device consists of an expandable polyurethane balloon that is placed in the nucleus space after the desiccated nucleus is removed. Then the balloon is filled with a flowable polymer. In the U.S., Disc Dynamics is completing its IDE feasibility clinical study.

Product Introduction and Update
Globus Medical launched the COALITION ACDF Spacer System. The device combines a PEEK interbody spacer with a titanium alloy plate and two titanium alloy screws, and the company says the design "reduces procedural steps, minimizes retraction and lags the spacer to the vertebral endplates to compressively load the fusion area."

Magellan Spine Technologies announced the first human implant of its Disc Annular Repair Technology (DART) System, which is used after lumbar discectomy. The device seals the annulus, and the company adds that it offers "structural integrity similar to interbody fusion devices and provides support to maintain disc height." DART received CE Mark clearance in April 2009, and the surgery was performed by Drs. Juan Dipp and Ricardo Flores at Hospital Y Centro Medico Del Prado in Tijuana, Mexico.

Intellectual Property
Unigene Laboratories Inc. received U.S. patent #7,531,518 for its Site-Directed Bone Growth (SDBG) technology. The company says the patent covers the induction of rapid, site-specific bone growth, which can then be preserved with a variety of therapeutic agents, including parathyroid hormone, calcitonin and bisphosphonates.

Legal
According to a regulatory filing, ArthroCare will pay $2.5 million to settle claims related to DiscoCare with State Farm Insurance. The company also agreed not to seek payment from State Farm on any pending SpineWand claims.

A federal circuit court reduced penalties Medtronic would pay to DePuy Spine related to a 2007 patent infringement case over Vertex multiaxial screws. The court affirmed $149.1 million in lost profits, but reduced damages and fees by a combined $87.7 million.

Clinical
According to new data from the ongoing SPORT trial, patients who received a decompressive laminectomy (with or without fusion) to treat degenerative spondylolisthesis associated with spinal stenosis reported better outcomes than patients who managed their condition with non-surgical care.

Operations
BSN Medical announced plans to expand its Charlotte-area facility by 50,000 square feet. The center currently houses distribution operations, but will be expanded to include manufacturing capabilities.

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