• Globus Medical (Audubon, Pennsylvania) reported the introduction of the Patriot signature TLIF spacer system designed for TLIF procedures. The Signature TLIF spacer is the latest addition to Globus Medical's portfolio of Milder Spine Care products. The Signature includes an articulating implant that enables surgeons to use a single instrument from insertion through final placement to deliver the spacer into the biomechanically ideal position through a portal or small incision. The ease of placement allows the surgeon to restore the natural lordotic alignment of the spine while employing an MIS approach. The system is designed to permit preservation of a significant portion of the musculature that lies between the skin and the surgical site on the spine while using a portal or mini-open technique.

• Medtronic (Minneapolis) reported the completion of enrollment in PROTECT, the company's global study comparing its Endeavor drug-eluting stent (DES) to Johnson & Johnson's Cypher DES. PROTECT is powered to detect a clinically significant difference in rates of stent thrombosis between the two devices. Stent thrombosis is a rare but serious adverse event in which a blood clot forms inside the stent, with the potential to cause heart attack or death. Occurrences after one year post-implant are called very late stent thrombosis (VLST) and a subject of significant concern. VLST emerged as a safety concern with the first generation of DES in 2006, when clinical trials conducted to support the regulatory approvals of these devices revealed a numerical increase in the rate of VLST compared to BMS controls. PROTECT's primary endpoint is overall stent thrombosis at three years; secondary endpoints include death and non-fatal myocardial infarction, target lesion revascularization and target vessel revascularization.

• Mpathy Medical (Raynham, Massachusetts) reported an extension of its surgical solutions for pelvic floor reconstruction. The newest additions include Restorelle A & Restorelle P for anterior and posterior compartment vaginal repair. Restorelle A & P are minimally invasive surgical solutions for the repair of anterior and posterior compartment defects through a single vaginal incision. Restorelle is constructed with a physiologically compatible mesh material Smartmesh Technology which was designed by a surgeon specifically for the female anatomy and delivers near-zero erosion rates, optimal tissue incorporation, and more collagen growth than heavier meshes. Both products were designed with the proper dimensions to meet the anatomical requirements for repairing the anterior and posterior compartment of the female anatomy, while leaving the least amount of mesh behind in the patient's body.

• Non-Invasive Monitoring Systems (Miami) said that the FDA has granted approval to NIMS to market Exer-Rest as a Class I (exempt) therapeutic vibrator with the following intended uses:"as an aid to temporarily increase local circulation, to provide temporary relief of minor aches and pains, and local muscle relaxation." Exer-Rest has the configuration of a single or twin bed and is fitted with a memory foam mattress. This medical device produces Whole Body Periodic Acceleration [vibration] (WBPA) to an individual (who lies horizontally on the mattress) through repetitive head-foot movements at approximately 140 times per minute during a 30 to 45 minute session. The movements are obtained by a patented motorized platform which is adjustable for speed, distance and time through a wireless digital controller. Non-invasive, drug-free WBPA treatments are usually administered daily five to seven days a week for symptomatic relief.

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