• Allergan (Irvine, California) reported the commercial launch of the Lap-Band AP system. The Lap-Band AP system is an evolution of the Lap-Band adjustable gastric banding system, currently the only FDA-approved adjustable gastric band for use in weight reduction for severely obese adults. A key feature of the Lap-Band AP system is Allergan’s 360-degree Omniform technology, which is designed to allow for an even distribution of pressure throughout the band’s adjustment range. The 360-degree Omniform inflation area of the Lap-Band AP distributes pressure evenly for complete coverage of the stomach anatomy. The Lap-Band is available in two sizes to meet the needs of a wider range of patients: the APS is the standard size and is indicated for most patients, and the APL is available for cases where a larger band is needed. Allergan makes products in the ophthalmology, neurosciences, medical dermatology, medical aesthetics, and obesity intervention markets.

• Kinetic Concepts (San Antonio, Texas) said that the FDA has cleared new claims across all care settings for two of KCI’s next-generation V.A.C. therapy systems: the InfoV.A.C. therapy system and the ActiV.A.C. therapy system. The FDA clearances include new claims that were granted after review of extensive clinical evidence provided by KCI and further differentiate V.A.C. therapy in the marketplace as the only negative pressure wound therapy systems specifically cleared by the FDA for all care settings, including home use. Digital images can be reviewed on-screen or transferred electronically to help document patient progress, allowing for the convenient sharing of wound information among caregivers and payers who require evidence of wound healing. The ActiV.A.C. will be used predominantly in the homecare setting and documents the patient’s therapy history and treatment times. Reports are electronically stored in the system and can be reviewed on-screen or downloaded to a computer. Kinetic Concepts makes wound care products.

Positive 12-month study results for the VALOR clinical study evaluating the Talent thoracic stent graft system, were presented during the annual meeting of the Society for Vascular Surgery in Baltimore. Sponsored by Medtronic (Minneapolis), VALOR is a test group patients with thoracic aortic aneurysms who were considered candidates for open surgical repair. The primary endpoint is “all cause” mortality at 12 months, comparing minimally invasive endovascular stent graft treatment to a historical surgical control group. The Talent system demonstrated 100% patency, which is a measure of the graft’s ability to resist collapse and remain open for proper blood flow, and there was a 99.5% success rate in deploying the stent graft. Also, the stent graft system used in the study was available in diameters ranging from 22 mm to 46 mm. Without this wide range of sizes, approximately 25% of the test arm patients in the VALOR trial would not have had the minimally-invasive stent graft therapy available to them as a treatment alternative.

• Sysmex America (Mundelein, Illinois) reported that the Sysmex UF-1000i automated urinalysis analyzer has been cleared by the FDA for sale in the U.S. The UF-1000i is a particle analyzer for the clinical laboratory, classifying urine formed elements with minimal operator intervention. The UF-1000i provides high precision counts for white blood cells and red blood cells, improved sensitivity for pathological casts, and enhanced analysis information for the screening of patients with kidney disease. Sysmex America makes clinical laboratory systemization and solutions, including clinical diagnostics, automation and information systems.

• Verathon (Bothell, Washington) reported the introduction of the GlideScope Cobalt, a single-use video laryngoscope that provides a real-time view of the patient’s airway, enabling quick intubation. GlideScope video laryngoscopes (GVL) provide a real time view of the airway and of endotracheal tube placement, minimizing the need for a “blind” intubation procedure. It consists of: a slim video baton which houses a high-resolution camera with a patented anti-fogging mechanism to resist lens contamination; a non-glare color monitor; and single-use, sterile GVL stats in large and small sizes that offer a patented 60-degree blade angulation. GlideRite tracheal tubes and a 90 degree rigid stylet, both used to facilitate intubation, are provided, along with a protective cradle for the video baton. Verathon makes non-invasive ultrasound devices.

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