A Medical Device Daily

Boston Scientific (Natick, Massachusetts) reported the launch of its Cognis cardiac resynchronization therapy defibrillator (CRT-D) and Teligen ICD in Japan. These devices were approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) in August and received reimbursement approval in September. Cognis and Teligen are the result of a multi-year research and development effort to provide physicians enhanced clinical options for their patients.

"Boston Scientific is committed to providing Japanese physicians and their patients the most innovative products and therapies," said David McFaul, Boston Scientific senior VP, International. "Cognis and Teligen are now part of Boston Scientific's full product portfolio in Japan, which also includes the company's newest and most advanced pacemaker the Altrua 60."

"The significantly reduced size of these devices has been well received by physicians in the U.S. and Europe, resulting in more than 75,000 implants in less than two years," said Ken Stein, MD, associate chief medical officer, Boston Scientific CRM. "In the past, physicians often had to make trade-offs among device size, battery longevity and features when prescribing a high-energy device. These devices eliminate those trade-offs without compromising therapy options."

The Cognis CRT-D and Teligen ICD are the world's smallest and thinnest high-energy devices at 32.5 cc and 31.5 cc respectively, while less than 10 mm thick. Both devices offer features based on substantial engineering advances, including extended battery longevity, self-correcting software and improved programming technology.

Both devices offer a redundant hardware system called SafetyCore, which provides life-saving shock therapy and basic pacing functionality in the unlikely event of a system error. The devices employ digital signal processing and are equipped with increased levels of digital memory, enabling more patient data to be captured and used by physicians.

CMT receives test approvals from SFDA

China Medical Technologies (CMT; Beijing), a China-based medical device company that develops, advanced in vitro diagnostic products, reported that the company has received approval for its Leukemia BCR/ABL fusion gene detection FISH Probe from the State Food and Drug Administration of China (SFDA).

The Leukemia BCR/ABL FISH Probe is a molecular diagnostic test kit that uses DNA probes for accurate detection of Philadelphia translocation, which is a specific chromosomal abnormality associated with chronic myelogenous leukemia (CML), acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML). Philadelphia translocation is the result of a reciprocal translocation between chromosomes 9 and 22. The translocation results in the presence of a fusion gene which is created by juxtapositioning of a part of the breakpoint cluster region (BCR) gene from chromosome 22 to the Abelson (ABL) gene on chromosome 9. CML, ALL and AML are some of the most common types of leukemia, and detecting Philadelphia translocation is a critical diagnosis and prognosis guidance for selecting different treatment protocols for patients with CML, ALL and AML.

CMT has received SFDA approvals for all the major FISH probes that the company acquired as part of the FISH business in March 2007, which include HER-2 FISH Probe, Prenatal FISH Probe, Cervical Cancer FISH Probe, Bladder Cancer FISH Probe and Leukemia BCR/ABL FISH Probe. The FISH probes that the company developed after its acquisition of the FISH business in March 2007, such as the EGFR molecular diagnostic kits, Prostate Cancer FISH Probe, Lymphoma FISH Probe, Sarcoma FISH Probe and FISH probes related to other forms of leukemia, are either in the clinical trial stage or under SFDA review.

"We believe we have become a leading developer and manufacturer of FISH probes in China with the most comprehensive FISH probes for clinical screening, diagnosis and prognosis," said Xiaodong Wu, CEO/chairman of CMT. "We believe our FISH probes will continue to drive a healthy growth for our company by generating sustainable and recurring revenue. We are also confident that our newly developed FISH probes will be approved by the SFDA in the future on a timely basis."

Merge in distribution accord with Pangaea

Merge Healthcare (Milwaukee), a medical imaging solutions provider, reported that its Merge China business unit has signed a distribution agreement with Pangaea Technology (Hong Kong), a distributor of CCD detectors, which are an economical alternative to digital detectors, for DR systems in the Greater China area. Pangaea will provide the Chinese DR market with a bundled solution consisting of Merge CIE (Cedara Image Enhancement) and CCD through their eight offices and wide distribution channels in China.

"After the healthcare reform plan was announced in China early this year, we recognized that there would be large demand for economical DR solutions in the rural healthcare market. Many local modality manufacturers have since switched their product lines to address a cost conscious, big volume market. We believe the CCD sensor and Merge CIE is a solution that will fit into this market perfectly," said Richard Fung, president/CEO of Pangaea.