Industry News

Bayer Schering Pharma has announced that it will launch a 30-gauge needle for its multiple sclerosis treatment Betaferon in the US.According to the company, this needle will be the thinnest needle of any injectable disease-modifying therapy for people with multiple sclerosis (MS). The needle is said to be as thin as those commonly used for insulin and pediatric injections.

Bausch & Lomb Has Approval for Akreos Advanced Optics Aspheric Lens. The FDA has given approval to market the product in the US. It is a single-piece, foldable acrylic intraocular lens with a four-haptic design and aspheric optics designed to be aberration-free. The company expects to begin shipping the Akreos AO lens to surgical facilities in September 2008.

Orthofix International has received 510(k) approval from the FDA for its new Pillar SA spine interbody device. The company also received a notification of approval to begin selling its CentroNail family of nailing systems in Japan.

Zimmer Holdings, a provider of spinal and trauma devices, dental implants, and related orthopedic surgical products, has announced that certain of its subsidiaries have agreed to acquire the Abbott Spine business from Abbott for approximately $360 million in cash.

Smart Disc, a US-based medical technology company focused on the development of spine products, has received US patent for the company’s artificial spinal disc technology. Smart Disc’s spinal replacement disc for the spine is said to mimic the functionality of the patient’s own intervertebral disc and can be put into place by the surgeon via a posterior application (thereby avoiding the need to go through the front of the patient, as is the current standard practice in disc
replacement).

Competitive Technologies has submitted an FDA application for pain management device. The device has CE certification for non-invasive, rapid treatment of high-intensity oncologic and neuropathic pain, including pain resistant to morphine and other drugs. The company has exclusive worldwide rights to this patented device. The device uses a multi-processor designed to create self-like neurons by applying surface electrodes to the skin to simultaneously treat multiple pain areas.

Cyberkinetics has sold its research products business to I2S Micro Systems Cyberkinetics Neurotechnology Systems for $982,000 in cash. The research products business provides neurotechnology equipment, including neural recording arrays, array insertion devices and data acquisition systems to academic researchers around the world.

Carticept Medical has announced that the first patients have been treated in a multi-center study of the company’s Agilus therapy. The study (380 patients)is designed to determine whether Agilus is superior to saline-control in reducing the debilitating pain associated with ankle osteoarthritis (ankle OA).

Spinal Restoration has announced that the FDA has approved an investigational device exemption pilot study (15 patients)of the Biostat Disc Augmentation System. The system consists of Biostat Biologx Fibrin Sealant, a human derived, biologic tissue sealant, and a proprietary application system designed to safely deliver the biologic to the intervertebral disc. The Biostat Disc Augmentation System has been specifically developed to address chronic low back pain resulting from
degenerative cracks and fissures which form within the intervertebral
disc.

Biosensors International Group has announced that a drug-eluting stent developed by the company has demonstrated equal safety and efficacy as compared to Johnson & Johnson’s drug-eluting stent, Cypher Select, based upon nine-month clinical and angiographic follow-up data.