• Ingen Technologies (Calimesa, California), manufacturer of the Smart Balance and OxyAlert product lines, reported that development of OxyAlert would be complete by Jan. 1 of next year. Ingen has contracted with Lifetime Controls (Arcadia, California) to complete the OxyAlert development. OxyAlert, which can function on any remote oxygen delivery system, is the second generation of the company’s BAFI product, a medical safety device that provides wireless and remote monitoring of oxygen delivery systems for patients and small aircraft, and falls under both of the issued U.S. patents held by the company.

• Medtronic Vascular (Santa Rosa, California) reported the completion of patient enrollment for the VALOR (Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms) clinical trial, a pivotal study evaluating the safety and efficacy of the Talent thoracic stent graft system for the treatment of thoracic aortic diseases. VALOR is a large thoracic stent graft study, with three arms and 359 patients at 40 clinical centers in the U.S. It is a prospective, non-randomized, multi-center trial with a primary endpoint comparing “all cause” mortality at 12 months for open surgical repair against minimally invasive endovascular stent treatment using the Talent stent graft system. Medtronic will use the results of the VALOR trial for submission to the FDA for approval of the Talent system. Final VALOR trial results may be available in 2006.

• Metrika (Sunnyvale, California), a manufacturer of diabetes monitoring products, said it received FDA marketing clearance for its new A1cNow INView multi-test system for monitoring hemoglobin A1C – the gold standard indicator of diabetes control. Used in a physician’s office or at home, the small monitor provides immediate, lab-quality quantitative A1C test results for determining a person’s average blood sugar level over the past two or three months. The test requires only a 10-microliter whole-blood sample via finger stick to obtain lab-quality results.

• Nephros (New York) reported receiving FDA 510(k) clearance for its OLpur HD190 high flux filter. The OLpur HD190 is designed for use in a variety of end-stage renal disease therapies, including hemodialysis and hemodiafiltration, and is labeled accordingly. The company said the HD190 shares a number of components and characteristics with its core OLpur MD190 filter, and that the approval should support the 510(k) process for its MD190 and H2H products.

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