A Medical Device Daily
St. Jude Medical (St. Paul, Minnesota) reported regulatory approval from Japan’s Ministry of Health, Labor and Welfare (MHLW), in addition to reimbursement approval, of the SJM Tailor Flexible Ring and SJM Tailor Flexible Band, the company’s first products in Japan for repairing diseased heart valves.
The Tailor Flexible Ring and the C-shaped Tailor Flexible Band are designed to provide surgeons with a range of easy-to-implant options for the repair of the heart’s mitral and tricuspid valves.
The Tailor Flexible Ring and Band are designed to accommodate the natural movement of the annulus, and St. Jude said physicians can tailor the products to meet precise patient needs. The Ring provides anterior and posterior support of the valve while allowing necessary motion as the valve opens and closes.
“With the approval and introduction of the Tailor Ring and Band, St. Jude Medical is offering its first valve repair solution in Japan, building on our long-established tradition of assisting Japanese surgeons with safe and effective solutions for the treatment of valve disease,” said Paul Bond, president, St. Jude Medical Japan.
St. Jude said it is the leading supplier of mechanical heart valves in Japan.
In 2005, the number of valve repair procedures performed in Japan increased more than 20% from the prior year, to nearly 6,400 procedures, according to statistics on thoracic and cardiovascular surgery (as reported in the September 2007 issue of General Thoracic and Cardiovascular Surgery). It is estimated that surgeries to repair faulty valves will continue to increase as the average age of the population increases.
The Tailor Flexible Ring and Band, which has already received regulatory clearance in the U.S. and Europe, will be launched immediately in Japan.
China SFDA approves VRIxp device
Deep Breeze (Beijing), a developer of Vibration Response Imaging (VRI) technology, said that China’s State Food and Drug Administration (SFDA) has approved the registration of its VRIxp device.
VRIxp is a non-invasive, radiation-free imaging system that creates dynamic functional imaging of the lungs. It was approved by SFDA for assisting physicians to diagnose and manage patients suffering from respiratory complaints.
With marketing approval of the device in China, Deep Breeze will market it via Ultimate Science Technology Co. to specialists and physicians at hospitals, clinics and screening centers.
The VRIxp device records lung vibrations from sensors applied to a patient’s back. The system then uses an algorithm to convert these data into a dynamic functional image. Changes in tissue composition and airflow affect the vibration intensity, dynamics and distribution within the lung which are then reflected in the image produced by the VRIxp system.
Deep Breeze said the system has been designed for the management and diagnosis of lung diseases such as COPD, lung cancer, pleural effusion and airway obstructions. It said better management “can accelerate the commencement of improve patient treatment.”
Singapore subsidiary set for bioMérieux
bioMérieux (Marcy L’Etoile, France) reported the opening of a subsidiary in Singapore. The company said this subsidiary, the company’s 38th, “is another milestone for [our] international expansion.”
It also advances bioMérieux’s Asian development strategy, following recent announcements of joint ventures in China and Japan.
The new subsidiary will host bioMérieux’s ASEAN team, supporting all of the ASEAN countries, South Korea, Australia and New Zealand. The Singapore-based team will consist initially of marketing managers, application specialists and field service engineers supporting bioMérieux distributors in the ASEAN countries, as well as regional business managers.
“We are taking one more step to increase our presence in Asia-Pacific, the region that will drive global growth in the 21st century,” said CEO Stéphane Bancel. “The expansion of our international network is critical for our company’s long-term sales growth and this greater proximity allows us to better serve our customers.”
bioMérieux, a developer of in vitro diagnostics, is present in more than 150 countries through 38 subsidiaries and a large network of distributors.
Added distribution accords for OraSure
OraSure Technologies (Bethlehem, Pennsylvania) reported the signing of new agreements to expand distribution of its cryosurgical wart removal product by Genomma Lab in the over-the-counter/consumer retail market in Central and South America.
In addition, the parties renewed and extended their prior distribution arrangement for Mexico and signed a new agreement to distribute the product in South Africa.
Under the agreements, the product will be manufactured by OraSure and sold under the Pointts trade name by Genomma Lab affiliates of Producciones Infovision to pharmacies and retailers in Mexico, Brazil, Argentina, a number of other Central and South American countries, and South Africa.
“We are pleased to expand our collaboration with Genomma Lab to make our cryosurgical wart removal product widely available to the consumer markets in Latin America,” said Douglas Michels, OraSure president/CEO.