• Acacia Research (Newport Beach, California) said that its CombiMatrix group (Mukilteo, Washington) has launched the ElectraSense Influenza Typing System based on CombiMatrix's electrochemical detection technology and its Influenza A Typing Microarray. The CombiMatrix Influenza A typing microarray can identify all strains of Influenza A, including the pathogenic H5N1 strain. Combi-Matrix is prepared to make this system available to domestic and international government agencies that are engaged in monitoring influenza and planning for a potential pandemic. Using this system, government agencies can verify, before disseminating potentially alarming information to the public, whether samples contain a highly pathogenic substrain of H5N1 or one of the several non-lethal substrains of H5N1. The portable system eliminates the bulk, complexity, delicate lasers, and fluorescent dyes common with existing technologies. CombiMatrix will seek FDA approval for the product.

• Medtronic (Minneapolis) reported FDA clearance of expanded labeling for its cardiac resynchronization therapy (CRT) biventricular pacing systems. The labeling revision reflects new clinical benefits of Medtronic CRT systems including reduced risk of all-cause mortality and unplanned heart failure or cardiovascular hospitalization, along with previously established outcomes of patients' reduction in NYHA Class, improved quality of life, and improved exercise capacity, among others. The FDA's labeling expansion was based on the results of CARE-HF (Cardiac Resynchronization in Heart Failure), a landmark clinical study sponsored by Medtronic. The study results, first presented during the American College of Cardiology conference in Atlanta, and concurrently published in The New England Journal of Medicine, demonstrated that CRT reduces hospitalizations and saves lives in many patients with moderate or severe heart failure and poor heart pumping function. In the study, CRT was shown to reduce all-cause mortality by 36% and unplanned hospitalizations for worsening heart failure by 52%.

• Patient Safety Technologies (Los Angeles) reported that its wholly owned subsidiary, SurgiCount Medical, has received FDA 510(k) clearance to market its Safety-Sponge System, which it said is the first computer-assisted program of counting sponges cleared by the FDA. The SurgiCount Safety-Sponge System is an integrated program of thermally affixed, data matrix tagged surgical sponges, line-of-sight scanning technology, and documentation that offers surgeons and hospitals a solution to gossypiboma - surgical sponges accidentally left inside a human body after surgery. Every surgical sponge and towel is pre-labeled by the manufacturer with an individual and unique bar coded label, and a scanning counter is used to read and record the labels. Sponges are counted and recorded by the system at the beginning of the procedure and again as they are removed from the patient, when a fail-safe alarm system immediately alerts the staff if any sponges are unaccounted for.

• St. Jude Medical (St. Paul, Minnesota) reported FDA approval and launch of its next-generation vascular closure device, the Angio-Seal VIP. The new device, which is approved for both diagnostic and interventional procedures, gives physicians an improved method for sealing arterial catheterization access sites. Because it provides more coverage on the artery surface than previous devices, physicians may more effectively achieve hemostasis, the company said. The device's coated suture enhances physicians' ability to effectively seal access sites, the company said. If physicians need to access the site a second time, they can safely re-enter with the Angio-Seal VIP device within 1 cm of the original site. All components, including a small anchor, collagen and a suture, of the Angio-Seal VIP are fully absorbed within 60 to 90 days.

• ThermoGenesis (Rancho Cordova, California), a developer of enabling technologies for cell therapy and wound care, reported that GE Healthcare (Waukesha, Wisconsin) has introduced the company's AXP AutoXpress Platform, the first automated, functionally closed, sterile system that harvests stem cells from cord blood with high yield and high throughput. The AXP platform is designed to bring automation and precision to cord blood stem cell processing, which is today performed using manual methods. GE Healthcare acquired the global exclusive distribution rights for the AXP Platform from ThermoGenesis in October 2005, as well as the non-exclusive distribution rights for its BioArchive System, a computer-controlled cryopreservation and storage system for cord blood.

• Wright Medical Group (Arlington, Tennessee), an orthopedic medical device company, has received FDA marketing clearance for use of its AlloMatrix Custom Biocomposite as a bone graft extender in the spine. The product is delivered to the customer in a freeze-dried, powdered form, ensuring that the DBM (demineralized bone matrix) proteins are preserved until mixed and prepared at the time of surgery, Wright said. The powdered DBM is combined with a high volume of large cancellous bone chips, enabling the surgeon to deliver high volumes of the patient's own osteogenic bone marrow to the fusion site to aid in the complex bone repair cascade. In a prospective clinical study comparing lumbar fusions using an autograft from the patient's iliac crest with AlloMatrix Custom Biocomposite combined with bone marrow aspirate and local bone, outcomes were found to be substantially equivalent. Patients treated with the AlloMatrix Custom Biocomposite are spared the additional operative time, blood loss, cost and discomfort common with the iliac crest harvesting procedure, the company said.