A Medical Device Daily

The Sorin Group, (Milan, Italy) reported the Japanese Ministry of Health, Labor and Welfare (MHLW) approval to market the Facil and Reply families of dual and single chamber rate responsive pacemakers.

The Facil and Reply families are based on the latest Sorin Group bradycardia platform. The Facil pacemaker is an 8 cc device, with no compromise on longevity. Reply offers the complete range of therapies in Facil with the addition of SafeR, the first algorithm able to switch between atrial-based pacing and dual chamber pacing modes. Both pacemaker families offer advanced therapy options for atrial fibrillation prevention, recommendations for optimal programming of the system, innovative functions to automate implant and follow-up procedures, and functions specifically designed for patient safety.

"The Reply and Facil families, based on Sorin Group's latest generation pacing platform, bring the best of our bradycardia technology to the market and offer a complete range of options for the treatment of bradycardia patients in Japan," said Stefano Di Lullo, president of Sorin Group Cardiac Rhythm Management Business.

The pacemakers will be distributed in Japan by Japan Lifeline Co. Ltd. a distributor of medical devices based in Tokyo.

Taiwan trial for Neuralstem

Neuralstem (Rockville, Maryland) reported that it has entered into a sponsored research agreement with China Medical University & Hospital of Taiwan (Taichung, Taiwan) to prepare for a human clinical trial using Neuralstem's human spinal cord neural stem cells to treat stroke patients.

The therapy will focus on patients whose post-stroke symptoms, including complete or partial paralysis, have stopped improving more than six months after an ischemic stroke. Ischemic stroke, caused by a blockage in a vessel supplying blood to the brain, is the most common type of stroke and affects more than 400,000 people in the U.S. annually. There are about 6.5 million stroke survivors in the U.S. alone.

Neuralstem President/CEO Richard Garr said, "The pre-clinical program, which we expect will take between nine months [and] a year, will focus on qualifying our existing cGMP (Good Manufacturing Process) spinal cord cells into a human trial program to treat post-stroke symptoms in Taiwan."

He added, "China Medical University is the national leader in innovative neurological research and treatments. We are very pleased to be working with another world-class institution, and with principal investigators Shinn-Zong Lin, MD, PhD, and Woei-Cherng Shyu, MD, PhD, as we build out our worldwide network of neurosurgical centers capable of conducting clinical trials, and ultimately delivering our cell therapies."

Neuralstem's technology enables, for the first time, the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells into mature, physiologically relevant human neurons and glia. The company is targeting major central nervous system diseases.

WatchPAT awarded Category III CPT code

The American Medical Association (AMA; Chicago) has awarded Itamar Medical's (Tel Aviv, Israel) WatchPAT device a Category III CPT (Current Procedural Terminology) code. A level III code will allow the medical community to begin the process of collecting much necessary usage information. This information, in turn, will be critical when the process moves to determining a reimbursement value for which a Category I code is expected in the near future.

In March WatchPAT was formally recognized by Medicare as being nationally covered for reimbursement across the U.S. The California Technology Assessment Forum (the technology assessment arm of Blue Shield of California) recently approved WatchPAT as directly affecting patient outcome out of 36 reviewed devices for sleep testing (only one other device was approved).

"We are excited to finally receive this important recognition of WatchPAT from the AMA. We are confident the medical community at large will benefit from the reliability and ease of use WatchPAT offers," said Dr. Dov Rubin, president/CEO of Itamar.

The company said that WatchPAT offers physicians the ability to fully analyze the 6 channels of tamper-proof, sleep-related data and manually edit the suggested automatic analysis in a manner similar to standard PSG (Polysomnograph) recordings.

Canada approves Covidien's ANDS

Covidien (St. Louis) reported that Health Canada has approved the company's abbreviated new drug submission (ANDS) for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection. Covidien's generic product is fully substitutable for Cardiolite, a myocardial perfusion imaging agent used for detecting coronary artery disease made by Lantheus Medical (Billerica, Massachusetts).

With Health Canada approval of the ANDS, which was filed by the company's Canadian subsidiary, Covidien's generic product is expected to be available for customers in Canada this summer. The company's generic product also is available in the U.S., the UK, Denmark, Germany and Puerto Rico.

"We are pleased to receive approval in Canada and to introduce this generic diagnostic option to meet patients' needs," said Timothy Wright, president, Pharmaceutical Products and Imaging Solutions, Covidien.