• AxioMed Spine (Garfield Heights, Ohio) reported the initiation of its pivotal clinical study of the Freedom Lumbar Disc, an elastomeric total disc replacement device. The Freedom Lumbar Disc is a viscoelastic one-piece, next generation total disc replacement, featuring a polymer core and was designed with the goal of restoring the natural function of the spine, thereby reducing pain and disability. The company's study is a multi-center U.S. and EU evaluation of the Freedom Lumbar Disc in skeletally mature patients with single-level degenerative disc disease and is designed with efficacy and safety as well as economic endpoints.

• GI Dynamics (Buenos Aires, Argentina) reported new data regarding the EndoBarrier, its noninvasive device currently in clinical trials to treat obesity and Type 2 diabetes. The EndoBarrier creates a physical barrier between ingested food and the intestinal wall, thereby changing the metabolic pathway by controlling how food moves through the digestive system. This mechanical bypass of the small intestine mimics the effects of gastric bypass surgery on a patient's metabolism, resulting in profound weight loss and remission of Type 2 diabetes. The EndoBarrier can be implanted and removed endoscopically via the mouth, without the need for surgical intervention.

• OtisMed (Alameda, California) said that a study showed that OtisKnee, its custom-fit approach to total knee arthroplasty (TKA), had positive results at three months post-surgery and reliably aligned the knee – showing that this approach may address the shortcomings of conventional and computer-assisted techniques. In the study, OtisKnee-assisted TKA had no adverse events, a short operative time, a high return of function and motion, high patient satisfaction at one month and three months follow-up, and repeatable alignment.

• Verax Biomedical (Worchester, Massachusetts) said its Platelet PGD Test for bacterial detection is now CE-marked. The company said the test holds potential to improve the safety of the blood supply by easily and quickly detecting a broad range of bacterial contaminants. The Platelet PGD Test is a disposable device designed to detect the presence of a broad range of bacterial contaminants in platelets at a later phase in platelet unit life than current culture methods. Bacterial contamination in platelets and red blood cells represents the single greatest risk for lethal infections in transfusion medicine today. The Platelet PGD is based on Verax Biomedical's PGD Bacterial Detection Technology, which targets common antigens found on the surface of all species of bacteria known to be pathogenic to humans.

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