A Medical Device Daily

Medtronic (Minneapolis) and Shandong Weigao Group Medical Polymer (Weigao, China) reported that they have agreed to form a joint venture to market products in the spine and orthopedics sector and that Medtronic would acquire a 15% equity interest in Weigao.

The j-v will handle Chinese marketing of Medtronic's spinal products and Weigao's orthopedic products, which include therapies for the hip, shoulder, spine and trauma. Under agreement, Medtronic will have a 51% interest in the j-v and Weigao a 49% interest.

Medtronic will purchase a 15% equity interest in Weigao for roughly HK$1,726 million ($221 million) by purchasing 80,721,081 newly issued H shares of Weigao listed on the Hong Kong Stock Exchange, at HK$11.138 a share and an equal number of Weigao's unlisted ordinary shares from the company's existing shareholders at HK$10.247 a share.

Medtronic will have the right to nominate two non-executive directors to Weigao's board as long as the U.S. firm owns 3.75% of the H shares.

Closing of the transaction is subject to various conditions, including approval of Chinese regulators and Weigao's shareholders.

"China is key to our global strategy as we continue to expand our geographic footprint," said Bill Hawkins, president/CEO of Medtronic. "Weigao has a broad orthopedic and trauma product line that complements [our] offerings, but even more importantly, we feel we can generate synergies with their very strong presence and reputation in China."

Chen Xue Li, Weigao's chairman, said, "We take great pride in forming a strategic alliance with Medtronic, the world's leading medical technology company. The collaboration will further broaden our business and raise our R&D capability, leveraging our extensive customer network and quality production, paving the way for Weigao to be the leading medical device company in Asia."

Weigao, based in Shandong province, said it is China's leading maker of medical devices and single-use consumables, including infusion sets, syringes, blood transfusion sets and blood bags, as well as orthopedic, cardiovascular stent and blood purification products.

Japan okays Sprint Quattro lead

Separately, Medtronic reported receipt of Japanese regulatory approval for the Sprint Quattro (Model 6944 and 6947) steroid-eluting right ventricular lead used with implantable cardioverter-defibrillators (ICDs) that detect and treat rapid and potentially lethal heart rhythms.

The Sprint Quattro 6947, with bipolar sensing and dual coil defibrillation, is Japan's first 8.6 Fr defibrillation lead to feature screw-in fixation. Screw-in fixation offers flexibility in securing the ICD lead in various right ventricle locations. The company said it hopes to receive reimbursement for Sprint Quattro by Jan. 1, which would allow for its immediate launch in Japan.

Approved in Europe and the U.S. since 2001, the Sprint Quattro 6947 lead has a proven performance record and patient safety profile, the company said, with established sensing and defibrillation capabilities. The lead is used with various ICD and cardiac resynchronization therapy devices, such as the Medtronic Concerto CRT-D and the Virtuoso VR ICD, both of which were introduced in Japan in July.

Pat Mackin, president and senior VP for Medtronic's Cardiac Rhythm Disease Management business, said, "The availability of the Quattro lead in Japan will provide Medtronic the opportunity to continue its market leadership in defibrillators and defibrillation leads in this important market."

Microcyn trials completed in China

Oculus Innovative Sciences (Petaluma, California) reported the completion of two randomized and controlled clinical trials - for burns and chronic wounds — of its Microcyn technology in China, conducted by its partner China Bao Tai.

The trial data has been submitted to the Chinese State Food and Drug Administration as the final step in securing agency approval to market Microcyn-based products in that country.

Johi Alimi, CEO and chairman of Oculus, said, "We are confident that these randomized and controlled studies will again validate the already positive results we have seen to date in 20 clinical studies in over 700 patients worldwide."

Oculus entered into an agreement with China Bao Tai earlier this year for the distribution of Microcyn-based products in China. The U.S. firm said the partnership allows it to gain a foothold in China through China Bao Tai's expertise in new product launches and what it termed a "large, well-connected distribution network."

Outside of wound care, China Bao Tai is evaluating the Microcyn technology in several indications. One intended study is designed to test Microcyn's safety and efficacy as a vaginal rinse for the treatment of yeast infections.

Yan Bing, president of Sinopharm, China Bao Tai's sub-distributor for hospitals and pharmacies, said, "The data from these randomized studies will bring timely SFDA approval and allow us to move into marketing the Microcyn-based products in early 2008."

Isotope-producing reactor re-booted in Canada

Canada's state-owned atomic energy company said earlier this week that it has reopened a nuclear reactor after that facility's shutdown created a critical shortage of radioactive isotopes used to diagnose and treat cancer patients in Canada, the U.S. and many other nations.

The National Research Reactor, located at Chalk River, Ontario, provides half the world's supply of the isotopes, which are used in about 25 million medical diagnoses and treatments each year.

The 50-year-old reactor was shut down Nov. 18 for maintenance and was scheduled to resume operation Nov. 23. But the Canadian Nuclear Safety Commission ordered an indefinite stoppage after discovering the reactor had been running for a year without the emergency power system being connected to two cooling pumps.

The reactor was safely returned to service last Sunday, Atomic Energy of Canada said. Officials expect to begin removing medical isotopes for processing and distribution within four days.

The announcement came just days after the Canadian government scrambled to pass legislation allowing the company to bypass Canada's nuclear safety watchdog and re-start the reactor immediately.

The reactor produces a radioactive substance called molybdenum-99, which is processed and packaged into canisters for hospitals and pharmacies.