A Medical Device Daily
Abbott Vascular (Santa Clara, California) said it has submitted an application for Shonin marketing authorization license to Japan's Ministry of Health, Labor and Welfare/Pharmaceuticals and Medical Devices Agency to gain approval for its Xience V everolimus-eluting coronary stent system to treat coronary artery disease.
The Shonin application for Xience V consisted of safety and efficacy data from the SPIRIT III clinical trial, including data from a Japanese population of 88 patients.
As previously reported, results from the SPIRIT III U.S. pivotal clinical trial demonstrated the superiority of Xience V over Boston Scientific's (Natick, Massachusetts) Taxus paclitaxel-eluting coronary stent system in the primary endpoint of in-segment late loss at eight months.
"Results of the SPIRIT III Japan Registry were very similar with those of the U.S. randomized clinical trial, which was the first head-to-head clinical trial to demonstrate the superiority of one drug-eluting stent over another drug-eluting stent," said Daniel Estay, divisional vice president, Abbott Vascular Asia Pacific and Japan.
The Xience V stent utilizes everolimus, which has been shown to reduce tissue proliferation in the coronary vessels following stent implantation, and is built upon Abbott's Multi-Link Vision coronary stent system, which the company called "the world's market-leading bare-metal stent."
Abbott said the Vision platform "has a flexible design and facilitates ease of delivery, making it easier for physicians to maneuver the stent and treat the diseased portion of the artery."
"The strong, positive data indicate that Xience V is a true next-generation drug-eluting stent that combines advanced technology with outstanding clinical benefits in the treatment of coronary artery disease," said Shigeru Saito, MD, director of cardiology and catheterization laboratories at Shonan Kamakura General Hospital and principal investigator for the SPIRIT III Japan Registry.
Canadian, Mexican approvals for Cepheid
Cepheid (Sunnyvale, California) reported that Health Canada has issued a medical device license for the company's Xpert GBS, for the rapid detection of Group B Streptococcus (GBS), and Xpert EV (enterovirus), for the rapid detection of EV-associated meningitis.
These tests join Xpert MRSA, which received a Health Canada license in January.
Cepheid also has received registration from the Secretary of Health in Mexico for its GeneXpert System and Xpert MRSA, Xpert GBS and Xpert EV tests.
The products will be distributed exclusively through I.L. Diagnostics in Mexico and Fisher Scientific in Canada.
"Regulatory licenses and registrations are critical in our efforts to effectively penetrate these new markets," said Rob Koska, senior VP, worldwide commercial operations. "Both Canada and Mexico will now have access to all of these high medical value-added diagnostic products that are improving patient care throughout the world."
As in the U.S., MRSA is a growing public health concern in Mexico. According to a study published in the Journal of Clinical Microbiology, "The prevalence of resistant bacteria has been increasing rapidly in Mexican hospitals during the last few years. According to different studies performed in the 1980s, 1990s and 2000, the prevalence of MRSA in Mexican hospitals was estimated to vary from 7% to 30%."
Emergo Group expands to Japan, China
Citing recent regulatory changes and what it terms an "export-friendly" exchange rate for U.S. manufacturers, Emergo Group (Austin, Texas) said it is expanding its medical device regulatory consulting services to China and Japan.
CEO Rene van de Zande said, "We have seen a significant increase in medical device companies that are searching for new sales opportunities beyond the North American and European markets. Part of the increased interest in Asian markets is due to a slowing U.S. economy, but manufacturers are also recognizing that a weak U.S. dollar makes it easier for them to compete in markets such as China and Japan."
Through a new office in Tokyo, Emergo said it now can help medical device manufacturers access the third-largest medical device market in the world, behind the U.S. and Europe.
The company offers assistance with Japanese pharmaceutical affairs law, quality management system implementation, reimbursement, medical distributor search and independent Designated Marketing Authorization Holder (D-MAH) representation.
Emergo Japan was recently awarded a license from the Japanese Ministry of Health, Labor and Welfare (MHLW) to act as an official D-MAH in Japan.
Increased demand from Emergo Group's current client base of 500 medical device companies led to its decision to establish a presence in Beijing. The company can now assist manufacturers seeking regulatory approval from the China State Food and Drug Administration (SFDA). Emergo can also act as a Legal Agent and After Sales Agent, a mandatory regulatory liaison to the SFDA for manufacturers with no presence in the country.
Emergo Group is an ISO-registered consulting firm that maintains offices in the U.S., Canada, Europe, China, Japan and Australia and assists manufacturers in all of these markets.
Pilot program in Australia for XTend Medical
XTend Medical (Sun Valley, California), developer of the Remote Diabetic Patient Monitoring System, reported that it will begin a pilot program with a large hospital group in Australia.
The initial program will encompass 20 patients, with a total target of 150 to 500 patients by year-end 2008.
"I'm extremely excited about this opportunity to place our product with a physician group outside the U.S.," said CEO Paul Lisenby. "Our continued marketing efforts have really paid off. We have seen a tremendous amount of interest in our product since the first of the year and we plan to close as many of these leads as we can from a global prospective."
He added, "This, coupled with imminent closing of several large managed care contracts here in the U.S. over the next few months, insures the company will have solid growth not only here domestically but also in the global telemedicine markets. We've received inquiries for our product from over 12 different countries to date."