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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 3-Sept-09 BY LAUREN UZDIENSKI, SEPTEMBER 3, 2009

Regulatory
Active Implants Corporation received a CE Class III Certificate for its TriboFit Hip System. The system is made from a low-wear polycarbonate-urethane material that the company says shares some of the characteristics of human cartilage.

MEDICREA received 510(k) clearance for its PASS LP Iliac Fixation system, which is designed to treat complex spinal deformities such as scoliosis, kyphosis, and lordosis. The company adds that the PASS LP Spinal System also includes pedicle screws, sacral plates, hooks and claws, rods and rod-plates, sacral/iliac screws and the UNIQUE line of active connectors.

Reimbursement
CMS will initiate a national coverage determination on ReGen Biologics' Menaflex, a collagen scaffold for the treatment of meniscal tears. The comment period will close on September 26th, with a draft determination to be made available next spring.

Product Introduction & Update
Integra LifeSciences launched the 5.5mm Coral cobalt chrome rods in a range of lengths for use in spinal correction and fusion procedures. The company says that the Coral Spinal System now offers three rod options, including rigid and malleable titanium rods.

Legal
MedIdea filed a patent infringement lawsuit against Zimmer relating to certain hip and shoulder patents.

Zimmer and Smith & Nephew settled a patent infringement case brought by Zimmer over a bone screw for anchoring a marrow nail. Terms of the settlement were not disclosed.

Collaborations
Cardea Technology, Inc. and Optasia Medical Ltd. will collaborate on a system for vertebral fracture assessment. Optasia Medical has developed the SpineAnalyzer, which identifies fractures on images, and Cardea Technology develops BoneStation, which is web-based imaging software. These products will be configured to such a report created by SpineAnalyzer can be displayed in the BoneStation interface.

Operations
Archus Orthopedics, which had been developing a facet joint replacement, has filed with the state of Delaware to dissolve the business. The company said they did not have sufficient capital to bring the product to market. Archus has raised more than $63 million since 2001.

Miscellaneous
NuVasive CFO Kevin O'Boyle is resigning from the company due to "personal and family obligations." Mr. O'Boyle will remain at NuVasive at least until December 31, 2009 to help recruit and train a replacement.

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