A Medical Device Daily
Boston Scientific (Natick, Massachusetts) said it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its Taxus Libert paclitaxel-eluting coronary stent system in that country. It said the Libert is the only second-generation drug-eluting stent approved for use in Japan.
The company said it plans to launch the product as soon as reimbursement approval is granted, which is expected in the coming weeks.
Boston Sci said design improvements over the first-generation Taxus Express2 stent include thinner struts to allow better stent deliverability and conformability, as well as a more uniform stent geometry for consistent lesion coverage and drug distribution.
Donald Baim, MD, chief medical and scientific officer of Boston Scientific, said, "The Taxus Liberté Stent is the latest advance in drug-eluting stent technology for Japan," said "Its safety and efficacy have been well demonstrated in multiple clinical studies and years of clinical use."
President/CEO Jim Tobin said, "We are very pleased with this approval, which provides access to proven technology to Japanese physicians and their patients."
The Taxus Libert stent uses proven paclitaxel-eluting technology, which has been evaluated by what Boston Sci characterized as "the industry's most extensive randomized, controlled clinical trial program," and studied in 35,000 real-world patients enrolled in post-approval registries. More than 4.6 million Taxus stent systems have been implanted globally.
The Taxus Libert will replace the Taxus Express2 stent, which was launched in Japan in May 2007. It has been approved for sale in the U.S., Europe and other international markets.
Australia's CSIRO develops sensor
The Commonwealth Scientific and Industrial Research Organization (CSIRO; Campbell, Australia) reported that it has developed a new concept of measuring surface pressure called the Acoustic Pressure Sensor (APS) and will release an Expression of Interest (EOI) form on Feb. 13 to find a partner who foresees commercial benefit in investing in the further development, production, clinical trials and global market development of the technology.
The sensor is made of an inert material and has no built-in electronics. When the sensor is subjected to sound waves, it reradiates some of the sound waves with the pressure information encoded within the reradiated sound waves. This allows the remote measurement of absolute pressure in the fluid that is in contact with the sensor.
CSIRO said an example of where the APS may be used is in the treatment of aortic aneurysms.
Such aneurysms usually are treated by the use of stent-grafts. If placed correctly, blood will flow through the stent graft and the blood pressure will be removed from the weakened sections of the aorta. If a stent graft is placed incorrectly, then the aneurysm is still exposed to direct blood pressure and it will keep on expanding, eventually rupture and potentially cause a fatal internal injury, CSIRO said.
It said that by placing the sensor on the outside of the stent graft and thereby excluding the aneurysm, the sensor will detect the change in pressure from systemic blood pressure to the lower, internal body pressure.
Medical Fair Thailand set for September
With the new name Medical Fair Thailand, the International Exhibition on Hospital, Diagnostic, Pharmaceutical, Medical & Rehabilitation Equipment & Supplies, will take place from Sept. 16 18 at the Queen Sirikit National Convention Center in Bangkok.
Formerly named Hospimedica Thailand, the event will again be organized by Messe Düsseldorf Asia, a subsidiary of Messe Düsseldorf in Germany, the organizer of MEDICA, the world's largest medical trade fair.
An expected 250 exhibitors from 24 countries will showcase the latest equipment for the medical industry, including diagnostics, electromedical and medical technology, dental equipment, laboratory technology, rehabilitation and orthopedic equipment as well as pharmaceutical supplies, emergency equipment, building technology and furniture.
More than 3,800 visitors are expected to attend.
Messe Düsseldorf Asia said the healthcare industry in Asia is growing steadily and is expected to gross $7 billion annually by 2012. It said Southeast Asia's governments have focused on revamping their healthcare systems. As a result, the medical equipment and supplies market is estimated to increase by 30% to a value of about $43 billion by 2010.