• AngioDynamics (Queensbury, New York) reported that it will launch the NeverTouch VenaCure procedure kit for laser treatment of severe varicose veins. The product will use a proprietary laser fiber technology designed to provide an enhanced level of perforation protection by further preventing contact between the fiber tip and the vessel wall during treatment. AngioDynamics makes devices for the minimally invasive treatment of cancer and peripheral vascular disease.

• Boston Scientific (Natick, Massachusetts) reported the launch of enrollment in its matrix and platinum science (MAPS) clinical trial designed to identify and investigate clinically relevant endpoints for evaluating the efficacy and durability of endovascular treatment of brain aneurysms. The trial's primary endpoint is target aneurysm recurrence, which is a composite endpoint comprised of target aneurysm re-intervention, target aneurysm rupture or re-rupture or death. Patients will be randomized to receive either Matrix2 detachable coils or GDC detachable coils. Boston Scientific makes GDC coils, a bare-platinum detachable coil cleared for aneurysm treatment, as well as Matrix2 coils, which are covered with a polyglycolic- polylactic acid bio-polymer.

• Cook Medical (Bloomington, Indiana) reports that a study that examined the times in which Cook's G nther Tulip vena cava filter could be successfully retrieved from patients has presented what it called "breakthrough" results. It said that clinical data revealed that the filter can be safely retrieved up to 12 weeks post-implant with a success rate of 94% when used for prevention of pulmonary embolism. The G nther Tulip is an implanted device used to capture blood clots caused by trauma, surgery or other medical conditions before they can reach the lungs, causing a pulmonary embolism. Cook Medical produces numerous medical devices.

• Cutera (Brisbane, California) reported clearance for its new laser, Pearl, with proprietary YSGG technology. Pearl is cleared for the treatment of wrinkles and represents the first application of the 2790 nm wavelength for cosmetic dermatology. During treatment, Pearl removes a portion of the epidermis with a controlled thermal effect. The thermal effect creates a natural protective dressing on the skin to minimize downtime during the restorative process. Cutera makes laser and light-based aesthetic systems.

• EndoGastric Solutions (Redmond, Washington) reported that it has received clearance for its StomaphyX device. StomaphyX is indicated for use in endoluminal transoral tissue approximation and ligation in the GI tract. So far, EndoGastric Solutions has specialized in the reconstruction of the gastroesophageal valve for the treatment of GERD. EndoGastric Solutions assists in endoluminal procedures for the treatment of gastrointestinal diseases, including GERD and obesity.

• EPIX Pharmaceuticals (Lexington, Massachusetts) reported an update regarding the status of its formal appeal to the Center for Drug Evaluation and Research (CDER) at the FDA, asking the CDER director to approve the company's novel blood-pool imaging agent Vasovist (gadofosveset trisodium injection). The appeal was submitted on Feb. 28, and the company said it is in discussions with the agency regarding the appeals process. It added: "Based on these discussions, it is now clear that the Agency's decision-making process will extend beyond the originally anticipated 30-day period." Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through MRA. EPIX Pharmaceuticals has five internally-discovered therapeutic and imaging drug candidates currently in clinical trials targeting conditions such as depression, Alzheimer's disease, cardiovascular disease and obesity.

• FoxHollow Technologies (Redwood City, California) reported submitting a 510(k) application to the FDA for its NightHawk plaque excision system. The intended use of the NightHawk System is in the evaluation of peripheral vascular morphology. The device uses fiber optic technology embedded in the catheter and allows the physician to visualize the vascular morphology and wall structures. The OCT embedded catheters are designed for use as an adjunct to conventional angiography to provide an image of the vessel lumen and wall structures. FoxHollow Technologies makes endovascular therapeutic devices for the treatment of peripheral artery disease.

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