• GI Dynamics (Lexington, Massachusetts) reported new data results that reveal changes in certain hormones in patients treated with the EndoBarrier gastrointestinal liner, which results in rapid improvement in glycemic control and weight loss. In the study, 17 obese patients with type 2 diabetes were treated with the EndoBarrier for 24 weeks. Each patient was evaluated to assess levels of HbA1c, glucose, insulin, GLP-1, GIP and PYY prior to and one week after placement of the EndoBarrier, and prior to and one week after removal, through blood draws conducted during meal tolerance tests. Treatment with the EndoBarrier resulted in: rapid and sustained increase in insulin sensitivity, increased levels of both PYY and GLP-1 one-week post-placement, reduction in mean HbA1c levels of 1.4%, normalization of glucagon response, and mean excess weight loss of 29.8%.

• MiCardia (Irvine, California) said an enCorSQ Mitral Valve Repair System patient in Stuttgart, Germany was the first to undergo treatment for recurrent mitral valve regurgitation (MR) without the need for a high risk surgical re-operation. The patient was surgically implanted with an enCorSQ device in April and, in August, presented with significant recurrent mitral regurgitation. The surgeons were able to adjust the enCorSQ device through a small incision and significantly reduce the level of regurgitation in less than one minute. The patient was released from the hospital the next morning. The MiCardia enCorSQ Mitral Valve Repair System is a mitral repair device with a permanently attached lead and a proprietary energy source, the MC-100 RF generator. The enCorSQ is constructed using a memory shape alloy core that has been designed to change its shape when its temperature is elevated a few degrees above body temperature. The device is implanted on the mitral annulus using conventional surgical techniques and the permanent lead is tunneled through the atrial wall and implanted under the skin in the chest or abdominal cavity. If mitral regurgitation recurs, days to months after the initial procedure, the permanent lead is exposed in a minimally invasive manner, using a small cut-down. The lead is then connected to its energy source, the MC-100. The shape of the device is changed, thereby reducing the anterior posterior distance of the mitral valve and eliminating or minimizing the recurrent regurgitation.

• Pall (Port Washington, New York) reported the introduction of the Sentino Microbiology Pump for microbial analysis of aqueous samples using the Membrane Filter (MF) Technique. The Sentino Pump streamlines analysis by replacing the traditional vacuum filtration system with a small peristaltic-action pump that draws aqueous samples through a membrane filter. Filtrate is channeled directly to drain or waste collection. The unit's compact design makes it easy to use in confined spaces and frees valuable benchtop space. It also provides flexibility in arranging workspace for optimal efficiency and workflow. A soft-touch keypad featuring on/off and pulse functions makes it easy to operate, with no complicated programming to validate. The Sentino Pump simplifies maintenance and contamination control in two ways: peristaltic action and disposable Fluid Path.

• pSivida (Watertown, Massachusetts) reported the opening of an investigational new drug application (IND) for a phase I/II clinical trial to study pSivida's injectable, sustained release insert delivering the corticosteroid fluocinolone acetonide (FAc) for the treatment of uveitis affecting the posterior segment of the eye (posterior uveitis). The insert is a third-generation insert based on pSivida's Durasert technology system. It is a tiny, cylindrical tube designed to provide a low, sustained dose of FAc for up to 36 months and is inserted by injection into the back of the eye in an office procedure. pSivida is focused on treatment of chronic diseases of the back of the eye using its core technology systems, Durasert and BioSilicon.

SpineGuard (San Francisco) reported the third published clinical study of its FDA-cleared and CE-marked PediGuard platform for enhanced pedicle screw placement has concluded that "the use of PediGuard significantly reduced the incidence of clinically relevant misplaced screws, thereby increasing the safety of pedicle screw implantation." PediGuard is a handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Real-time feedback is provided via audio and visual signals. Nearly 17,000 procedures have been performed with PediGuard. Multi-center clinical studies of PediGuard have been published demonstrating that PediGuard doubles the pedicle breach detection rate, limits radiation exposure by 30%, and decreases by up to 10% the average time for pedicle screw placement.

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