Regulatory
Corin received FDA approval for its Cormet Hip Resurfacing System on Tuesday, following an approval recommendation from an FDA Advisory panel back in February. Conditions of the official approval include the creation of a surgeon education protocol that emphasizes patient selection criteria. The Cormet system will be distributed by Stryker, with whom Corin has a 10-year U.S. distribution agreement. The device could be available as early as Q3:07.
Artimplant received FDA approval for its Artelon® STT Spacer. The device will be distributed by Small Bone Innovations and is indicated for osteoarthritis in the STT joint.
Reimbursement
This week CMS released a proposed rule for 2008 policy and payment changes. Following the Congressional reversal of 2007's proposed payment cuts, 2008 will see a 9.9% reduction in physician payments.
License Agreement
Pioneer Surgical Technology entered into a license agreement with AlpineSpine, LLC for global rights to LowTop, Alpine's pedicle screw locking system and cross-link design. Terms were not disclosed.
Clinical
Genzyme announced that results from a clinical trial comparing hylastan to steroids did not demonstrate the superiority of hylastan for pain relief. The multi-center, double-blind study among 400 patients showed that hylastan did reduce pain, but the difference in pain reduction between patients treated with hylastan and patients treated with a steroid was not significant. The Company will focus their efforts on developing a separate product, Synvisc-One, whose successful pivotal study was presented last month at the Annual European Congress of Rheumatology.
SpinalMotion has finished enrolling its IDE trial for the Kineflex®/C cervical disc implant. The study will be conducted 20 U.S. centers and have a two-year follow-up period; the company is simultaneously conducting an IDE study for its lumbar disc. The studies combined have enrolled almost 800 patients.
