A Medical Device Daily

Boston Scientific (Natick, Massachusetts) reported receiving approval from Health Canada's Therapeutic Products Directorate for sale of its Taxus Liberté paclitaxel-eluting coronary stent system in that country.

The company said it plans to launch the stent immediately in Canada.

"The Taxus Liberté Stent is a major advance in stent development and raises the bar for drug-eluting stent systems," said Serge Doucet, MD, cath lab director at the Montreal Heart Institute. "It offers enhanced ability to conform to the vessel wall and deliver across some of the most challenging lesions. This [approval] is welcome news for interventional cardiologists and patients in Canada who suffer from coronary artery disease."

David McFaul, senior VP, international, for Boston Scientific said, "This stent is designed specifically for improved drug elution and deliverability. Coupled with our proven paclitaxel-eluting technology, Liberté provides physicians with next-generation performance."

Boston Scientific said its Taxus stents are the global market leader, and have been evaluated "by the industry's most extensive randomized, controlled clinical trial program, as well as studied in more than 35,000 real-world patients enrolled in post-approval registries."

To date, about 4 million Taxus stents have been implanted worldwide.

The Taxus Liberté previously was approved for sale in Europe and other international markets and is awaiting approval by the FDA.

TomoTherapy to buy Chinese company

In other China news, TomoTherapy (Madison, Wisconsin), maker of the Hi Art radiation therapy system, said it has entered into an agreement to acquire privately held linear accelerator manufacturer Chengdu Twin Peak Accelerator Technology (Chengdu, China). Financial terms of the deal were not disclosed.

A linear accelerator is a key component in radiation therapy systems, used to create high-energy X-rays for cancer treatments. The linear accelerators designed, developed and manufactured by Twin Peak will be used to supplement TomoTherapy's existing supply source.

TomoTherapy CEO Fred Robertson said, "The acquisition of Twin Peak represents a substantial advance in our ability to control the quality and features of our products. This also is a piece of our longer-term strategy of reducing the cost of the Hi Art treatment system to improve margins."

TomoTherapy said it anticipates that the transaction will close in about 90 days.

TomoTherapy's Hi Art system is an advanced radiation therapy system for the treatment of a variety of cancers. The system combines integrated CT imaging with conformal radiation therapy to deliver treatments with speed and precision while reducing radiation exposure to surrounding healthy tissue.

Chinese approval for Calypte test

Calypte Biomedical (Lake Oswego, Oregon), a manufacturer of HIV diagnostic tests, said that its Chinese subsidiary, Beijing Marr Bio-Pharmaceutical, has received registration and marketing approval for the Aware HIV-1/2 OMT (oral fluid) rapid test from the State Food and Drug Administration (SFDA) of China.

The company said the approval makes the Aware OMT test the first SFDA-approved rapid oral fluid HIV test in China.

The Aware product is a rapid test using oral fluid to diagnose HIV-1 or HIV-2 infection in as little as 20 minutes, with an accuracy, according to Calypte, comparable to that of FDA-approved, blood-based laboratory HIV EIA tests.

Roger Gale, CEO and chairman of Calypte, said, "We are [pleased] to have received this long-awaited approval, which permits us to begin actively marketing our rapid diagnostic tests in China, one of the potentially largest HIV testing markets in the world."

He said that with the medical devices manufacturing permit received earlier this year, Calypte's Beijing Marr subsidiary is now able to manufacture, market, distribute and sell the Aware HIV-1/2 OMT test throughout China.

"China is committed to aggressively tackle the spread of its HIV epidemic and we believe that our Aware oral fluid test can and will make a significant contribution to that effort," Gale said.

He added: "this approval also gives us, for the first time, a valuable approval in the country of manufacture. Absence of this approval in the past has hampered our ability to register and market the test in a number of countries, a hurdle we can now overcome by producing the domestically approved Aware product in our Chinese factory. We are now in a position to market and sell in countries representing a total population of nearly 3.7 billion, or over half of the world's population."

David Harris, CEO of Beijing Marr, said, "We have already received numerous inquiries from HIV program managers and scientists eager to use the product here in China. We now plan to ramp up our production capacity as we build our distribution network to fully realize the market potential of the Aware HIV-1/2 OMT test in China."

1st VeinViewerGS units shipped internationally

Luminetx (Memphis, Tennessee) reported it has shipped its first VeinViewerGS units overseas, marking the company's entrance into the international marketplace. The "GS" unit, standing for "Global Standard," was designed to meet the quality requirements for the international marketplace.

The VeinViewer is an imaging system that allows physicians, nurses and other healthcare professionals to clearly see accessible vasculature, or the lack thereof, in real time.

The device uses a combination of near-infrared light and patented technologies to image vascular structures and projects their location directly on the surface of the skin. This provides clinicians with a safe, non-invasive adjunct technology for clinical treatments and procedures, including, but not limited to, IV insertions, PICC line insertions, routine venipuncture, blood and plasma donations and treatment for varicose and spider veins.

Last December, the VeinViewer technology received EC and ISO 13485:2003 certifications, allowing shipment to European countries and continuing the expansion of the Luminetx global strategy.

The new generation of the VeinViewer meeting these European quality certifications is known as the VeinViewerGS model, which will be offered to both international and domestic clients as the company's flagship product.