A Medical Device Daily
NeuroVasx (Maple Grove, Minnesota) a medical device company that develops technologies for the treatment of hemorrhagic and ischemic stroke, reported that it has received approval to market its cPAX aneurysm treatment system in Canada from Health Canada's Therapeutic Products Directorate. In addition to Canadian regulatory approval, the cPAX System also received the CE mark in March 2009.
"This approval allows for our first commercial entry into the North American market and is another milestone in our effort to expand patient access to the cPAX System," said Eric Timko, president/CEO of NeuroVasx. We continue to work with the FDA on our 510(k) submission for cPAX and look forward to potential U.S. regulatory approval and commercialization in the near future," he added.
The cPAX System is a minimally invasive device for the embolization of cerebral aneurysms, abnormal bulges or sacs in the wall of an artery in the brain. If ruptured, aneurysms can result in massive intracranial bleeding and often lead to death.
cPAX is a polymer strand delivered through a microcatheter using the same delivery technique as the currently used platinum coil technology. cPAX was designed to achieve more complete filling of the aneurysm using fewer devices and provide the physician the ability to detach the device at any point vs. the fixed detachment zone common to platinum coils. The polymeric material also allows for non-invasive CT and MRI scans free of metallic artifact for a more accurate patient follow-up assessment.
Fluidigm (South San Francisco) reported that its Singapore biochip factory has manufactured and shipped more than 250 million microscopic NanoFlex valves. The 250 million valves built into Fluidigm's integrated fluidic circuits (IFCs) would be equivalent to the number of valves required for all the conventional plumbing – both residential and commercial – in a metropolitan region the size of the San Francisco Bay Area.
Fluidigm's NanoFlex valves stop or release the flow of liquids containing genetic samples and reagents in microfluidic chips. These chips are used by life science researchers to conduct endpoint, real-time and digital PCR analyses. Scientists utilize this technology to explore everything from individual stem cells and cancer cells, to the traits of tomatoes being grown for your local grocery store shelf. These manufactured valves are so small and precise that they can isolate a single cell or DNA molecule, permitting researchers to detect the mutation of a cell into a cancerous state much earlier than standard techniques, or non-invasively detect Down syndrome in a fetus.
In 2005, Fluidigm opened Singapore's first biochip factory and it is now the world's leading manufacturer of microfluidic devices, the company said. Today, the factory manufactures both IFCs and associated instruments/systems, as well as conducts research and development in coordination with the company's South San Francisco operations.
"I never doubted that one day biochip manufacturing would move into the mainstream and that Fluidigm's Singapore factory would be leading the parade," said Grace Yow, Fluidigm vice president of worldwide manufacturing and Fluidigm Singapore's managing director. "Our multi-layer soft lithography manufacturing builds on technologies developed in the semiconductor industry. Singapore has a stellar reputation for its semiconductor manufacturing capabilities, so we were confident that we could find and train highly-skilled workers to build high-quality, high volume biochips for the life science industry," Yow added.
Spacelabs reports new global USCOM launchesM
Spacelabs Healthcare (Issaquah, Washington) reported the launch of the Ultrasonic Cardiac Output Monitor (USCOM) in several new geographies, including Latin America, Africa, Europe, Australia and Middle East. USCOM's non-invasive method of cardiac monitoring is designed to provide an accurate, safe and efficient way of measuring how well the heart is functioning.
The company noted that USCOM is the only non-invasive device to provide beat-to-beat performance of both the left and right side of the heart. Portable and user-friendly, USCOM revolutionizes care in all areas, including emergency, intensive care, and general practice, the company said. However, USCOM's most dramatic impact may well be in pediatric intensive care, a population that traditionally could not be safely monitored due to the invasiveness of conventional cardiac output technologies. Now, with USCOM, infants and children can be monitored non-invasively, without risk of infection.