• Edwards Lifesciences (Irvine, California) reported U.S. launch of its ThermaFix tissue treatment process, which will now be available on the company's Carpentier-Edwards Perimount Magna replacement tissue heart valves. It said the new combination of technologies is being unveiled at this week's 41st annual scientific meeting of the Society of Thoracic Surgeons (STS) in Tampa, Florida. Edwards co-developed the ThermaFix process with biochemist Sophie Carpentier, PhD, and her husband, Professor Alain Carpentier, chairman of the department of cardiovascular surgery at the Hopital Europeen Georges Pompidou (Paris). Edwards said that laboratory studies have demonstrated that, when compared to its current market-leading tissue treatment, the ThermaFix process “significantly reduces leaflet calcification, which is one of the primary causes of tissue valve deterioration.“ The Perimount Magna valve, an aortic replacement tissue heart valve constructed of bovine pericardium, is designed specifically to optimize patient blood flow and facilitates placement above the patient's native valve opening, which may allow surgeons to implant a valve that is larger than other conventional tissue valves. During the STS meeting, Edwards also is showcasing its portfolio of heart valve therapy and cardiac surgery products, featuring a “Countdown to Innovation,“ at its booth and highlighting its Carpentier-McCarthy-Adams IMR ETlogix annuloplasty ring, designed for the requirements of ischemic mitral heart valve repair, and its Carpentier-Edwards BioPhysio aortic valve, a next-generation replacement heart valve currently in clinical trials, designed to replicate the physiologic motion of a natural heart valve.

• Immunomedics (Morris Plains, New Jersey) reported that the Biologics and Genetics Therapies Directorate at the Health Products and Food Branch of Health Canada approved the marketing and use of LeukoScan (sulesomab) for the detection of osteomyelitis. Nuclear medicine imaging with LeukoScan has been shown to be highly sensitive for detecting osteomyelitis in patients with diabetic foot ulcers and may also be useful for monitoring the efficacy of antibiotic treatment. LeukoScan preferentially binds to activated granulocytes in the blood stream and at the site of infection. Because more activated granulocytes are at the site of infection than in circulation or bone marrow, there is less non-specific activity. The product will be distributed in Canada by GE Healthcare Medical Diagnostics (formerly Amersham Health).

• Non-Invasive Monitoring Systems' (North Bay Village, Florida) Acceleration Therapeutics Division reported that the FDA has reclassified the flagship product of the company, the AT-101 device, from its listed FDA Class 1 (exempt) powered exercise device to a therapeutic vibrator requiring 510(k) submission. The FDA made this determination because it believes that the AT-101 “exceeds the limitations to the exemption in 21 CFR 890.9(a) and (b) because it introduces new indications and new technology for therapeutic vibrators,“ according to the company. Accordingly, the company cannot market the AT-101 device until it has received an allowance letter from the agency. Non-Invasive Monitoring said it is weighing its options for response to the FDA action and considers this “a matter of serious concern“ to its business.

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