Orthopedic News Roundup 28-June-07
BY LAUREN UZDIENSKI, JUNE 28, 2007
Regulatory
Life Spine announced 510(k) clearance for its static anterior cervical plating system Neo®-SL. The system features an integrated lock that allows bone screws to be securely fixated without any additional locking components.
The FDA approved new labeling for Genzyme's Carticel®. The updated label incorporates safety and effectiveness data from the company's four-year post-marketing STAR study.
ReGen Biologics responded this week to the FDA's request for additional information regarding the company's 510(k) application for its collagen scaffold device. The company believes material submitted already is sufficient to show substantial equivalence, and ReGen is working with the FDA to resolve the agency's questions.
Pegasus Biologics received the CE Mark for its OrthADAPT™ Bioimplant, a collagen scaffold used in soft tissues. According to the company, Pegasus' crosslinking and sterilization technologies make the implant resistant to premature enzyme degradation and biocompatible to allow remodeling.
The Swedish Medical Products Agency (MPA) announced its response to Nobel Biocare's plan to improve information regarding its NobelDirect and NobelPerfect dental implants. The agency stated that Nobel needs to provide more information than outlined in their previous labeling proposal, incorporating information including measures to avoid bone resorption, dentist qualifications and warnings and cautionary measures disclosures.
Lawsuits
A California court ruled in favor of Depuy Spine and dismissed most liability claims relating to the Charite artificial disk on the grounds that FDA approval was preemptive.
In a case that could have broad implications for the medical device industry, the Supreme Court announced plans to hear a Medtronic case involving a failed balloon catheter. Traditionally, federal preemption results in dismissal for most product liability cases, but the Medtronic decision could change that. Reigel v. Medtronic will be heard when the Court opens its next term this fall.
License Agreements
Orthopedic Development Corp. subsidiary minSURG has partnered with Bauerfeind to create a brace for use with minSURG's TruFUSE™ technique. According to the press release, the TruFUSE procedure "requires post-surgical back support, to be worn for a minimum of six weeks to ensure fixation."
Effective May 1, Premier Purchasing Partners entered into separate 36-month agreements with ConMed and Smith & Nephew to offer arthroscopy equipment to Premier member hospitals in the U.S.
Product Introduction & Update
ApaTech announced the U.S. launch of Actifuse™ ABX E-Z-fil Putty. Indications include posterolateral spine fusion with stabilizing hardware (PLF) in addition to general bone void filler applications; the company notes that this is the first time a synthetic graft material has been indicated for PLF in the U.S.
K2M launched the RANGE™ Spinal System, which incorporates features from the MESA™ and DENALI™ Spinal Systems. The RANGE system is indicated for disorders including deformity, trauma, tumor and complex degenerative diseases.
Globus Medical launched the CITADEL™ Anterior Lumbar Plating System, the company's 26th complete system in four years. Globus states that the system can be used throughout the entire range of the lumbar spine, not just the lumbosacral junction; the sacral plate is specially designed to match the curvature of the sacrum; the plate provides large visualization windows; and the system utilizes both fixed and variable screws. To date, more than 40 surgeries have utilized the Citadel system.
Omni-Tract Surgical, Inc. launched the GhosTract radiolucent retractor kit for anterior lumbar spine procedures. GhosTract retractor blades are translucent, allowing for x-ray imaging during surgery.
INBONE Technologies announced the implantation of its 100th total ankle at the University of Alabama, Birmingham. The INBONE™ total ankle was first used externally eight months ago.
Clinical
A minimally-invasive surgical procedure combined with parathyroid hormone (PTH) was shown to strengthen bone in animal studies, according to data presented by Unigene Laboratories, Inc. and Yale University at the 17th Scientific Meeting of the in Montreal. The presentation will be on Unigene's website this week.
Appointment
SpineVision named Bertrand Lellouche Chief Financial Officer. According to the press release, Mr. Lellouche brings to SpineVision more than 15 years of experience in international financial management. Previous posts include serving as Vice President and Chief Financial Officer at Biomedical Diagnostics and Vice President of Finance & Operations for GenOdyssee, a French-based drug discovery company.
Scient'x USA announced that Federico P. Girardi, M.D. will be joining their Scientific Advisory Board. Dr. Girardi is an Assistant Attending Orthopedic Spine Surgeon at the Hospital for Special Surgery in New York City and also serves as an Assistant Professor of Orthopedics at the Weil Medical College of Cornell University.
Miscellaneous
Cytori will voluntarily delist from the Frankfurt Stock Exchange (FSE) on September 25, 2007. The company said that the reason for delisting is the significant trading volume on the NASDAQ, where Cytori has its primary listing. Once the stock is delisted from the FSE, shares owned in Germany or elsewhere can continue to be traded on the NASDAQ under the symbol CYTX.
