A Medical Device Daily

Abbott (Abbott Park, Illinois) reported that the Chinese State Food and Drug Administration (SFDA) has approved its Xience V everolimus-eluting coronary stent system for the treatment of coronary artery disease (CAD) the leading cause of death in China. The company plans a fourth-quarter launch for Xience V in China, which is the second-largest drug-eluting stent market in the Asia-Pacific region after Japan. With approval in China, Xience V is now available in every Asia-Pacific market except Japan, where approval is anticipated at the end of this year.

"Since it first became commercially available in 2006, Xience V has become the market-leading drug eluting stent around the world due to its excellent outcomes and outstanding deliverability," said Robert Hance, senior VP, vascular, Abbott. "As the incidence of heart disease and the number of annual stent procedures continue to increase in China, it is critical for physicians and patients to have access to one of the most advanced drug eluting stent technologies. We look forward to making Xience V available in China."

According to the China Chronic Heart Disease 2006 Annual Report, nearly 50% of all deaths annually in China are due to CAD, and the prevalence of coronary artery disease has steadily increased each year. About 150,000 patients annually undergo a stent procedure for the treatment of CAD, and the number of procedures is growing by more than 20% each year in China.

"Heart disease is a serious health issue in China, with more patients being diagnosed each day, so it is critical to have access to advanced technology, such as Xience V, that can help improve patient outcomes," said Run Lin Gao, MD, VP, Chinese Medical Doctor Association.

Chinese company exports pain patch to Canada

China Sky One Medical CSOM; (Harbin, China) reported that it has begun to export its Pain Relief patch to Canada. The first order included 40,000 patches, which are now available in some stores and supermarkets in Vancouver.

"We are excited to have our Pain Relief patches enter the Canadian market and see a lot of opportunity," said Yan-qing Liu, chairman/CEO of China Sky One Medical. "We are now working with sales agent to estimate future sales volumes. Looking forward, we will put more effort into expanding distribution of our products into North American markets as we seek to further increase profitability and shareholder value."

CSOM, a Nevada corporation, is a holding company. It engages in the manufacturing, marketing and distribution of pharmaceutical, medicinal and diagnostic products.

Winner obtains Chinese HNTE certificate

Winner Medical Group (Shenzhen, China), an exporter of medical dressings and medical disposables in China, reported that its subsidiary, Winner Industries (Shenzhen) obtained the High and New Technology Enterprise certificate granted by the Ministry of Science and Technology of China, the Ministry of Finance and the State Administration of Taxation.

As a result of this new status, which will be reevaluated by Chinese government authorities every three years, Winner Shenzhen will enjoy a 15% corporate income tax rate for calendar years 2009, 2010 and 2011. Currently, Winner Shenzhen contributes to about 80% of the company's consolidated net profit. Before receiving this certificate, the company was subject to the new PRC Enterprise Income Tax Law, effective on Jan. 1, 2008, which gives existing foreign investment enterprises a five-year grandfather period, with an income tax rate of 18% in 2008 for enterprises located in Shenzhen, which will increase to 20%, 22%, and 24% in years 2009, 2010, and 2011 respectively, reaching 25% in 2012 and thereafter.

"The recognition of the High and New Technology Enterprise Certificate reflects our continued strength and progress in fundamental areas such as research and development and product commercialization. As a high technology enterprise, Winner Medical benefits substantially from this status in reducing our expenses and increasing our profits," said Jianquan Li, president/CEO of Winner Medical.

Winner develops medical care products, wound care products, home care products and PurCotton products. The products are sold worldwide, with Europe, the U.S. and Japan serving as the top three markets.

Cardiac Sci in agreement with India's Patni

Cardiac Science (Bothell, Washington), a provider of automated external defibrillator (AED) and diagnostic cardiac monitoring devices, reported a three-year agreement with Patni Computer Systems (Mumbai, India) under which Patni will establish a dedicated design center in India and will expand Cardiac Science's existing in-house design and development capability.

"One of our strategies is to increase the volume and frequency of new product introductions, particularly in cardiac monitoring. We have great brands and distribution channels we want to better leverage," said Dave Marver, Cardiac Science president/CEO. "This agreement provides us the resources and flexibility to pursue multiple new product development initiatives simultaneously."

Patni specializes in the design and engineering of Class II and III medical devices and is a global leader in providing high-quality, reliable, and cost effective Product Engineering and IT Services. Ajay Chamania, Patni's EVP and global head of product engineering services, said, "Patni has several years experience helping companies in the medical device industry reduce time and cost to market while ensuring complete regulatory compliance. We are thrilled with the opportunity to do the same for Cardiac Science."

"Our mandate is to increase the speed-to-market while keeping costs in check," said Bob Odell, senior VP of strategy, design, and operations for Cardiac Science. "This agreement, like the Syncroness relationship we announced earlier this year, dramatically increases our engineering capacity and allows internal team members to focus on changing market dynamics, new customer solutions, and new revenue opportunities."