• Candela (Wayland, Massachusetts) said it would introduce next-generation I2PL technology for skin rejuvenation of vascular and pigmented abnormalities. Through a partnership with Danish Dermatologic Development (DDD), Candela will expand its product portfolio to include the new Ellipse I2PL system. Candela is the exclusive distributor for the Ellipse intense pulsed light system in the U.S., which is pending FDA clearance. The Ellipse features a lightweight, ergonomically shaped hand- piece and allows effective treatment of large or small areas of sun-damaged skin. Ellipse is the only intense pulsed light system to feature DDD's I2PL technology, which removes “water absorbing“ wavelengths from the output spectrum device.

• Colours In Motion (Corona, California), a designer of everyday, sport and pediatric wheelchairs, said its new Spazz-G wheelchair features expandable seat width and depth, as well as adjustable positioning. The contoured frame is designed to be not only stylish, but also practical since it is easy to pull into the car and over the steering wheel. At 19 pounds, including wheels, the company said it is sleek, lightweight and easy to lift. The Spazz-G's main rigid axle tube provides durability, rigidity and support. Its positive locking adjustable backrest offers a full range of backrest angle settings.

• Edwards Lifesciences (Irvine, California) reported receiving conditional approval from the FDA to begin the first feasibility trial of its Cribier-Edwards percutaneous aortic heart valve. Edwards will conduct an initial feasibility study at a single U.S. center involving a randomized, controlled clinical trial of 20 patients who are at a defined level of high risk for conventional heart valve surgery. Under the study's protocol, equal numbers of patients will be randomized to percutaneous aortic valve replacement and balloon aortic valvuloplasty. Upon successful completion of this study, Edwards will initiate a second feasibility trial, which would enroll an additional 40 patients at a limited number of sites. The Cribier-Edwards percutaneous aortic heart valve integrates balloon-expandable stent technology with a replacement tissue heart valve that is compressed onto the balloon. Percutaneous heart valve replacement can be performed without opening the chest and under local anesthesia.

• Proxima Therapeutics (Alpharetta, Georgia) said that its MammoSite Radiation Therapy System is expected to be the primary method used to deliver partial breast irradiation (PBI) in a new National Cancer Institute-sponsored study. The National Surgical Adjuvant Breast and Bowel Project and the Radiation Therapy Oncology Group, both clinical trials cooperative groups supported by the NCI, have issued a protocol for the largest study of partial breast irradiation to date. The 3,000-patient study will further define the role of PBI, a treatment option that makes breast conservation therapy available to more breast cancer patients by delivering radiation in just five days. In addition to playing a key role in this study, Proxima said MammoSite is the most widely used form of PBI in the world. MammoSite is an FDA-cleared balloon catheter that is placed in the cavity created by a lumpectomy. After implantation, radiation is delivered from a source placed inside the balloon directly to the tissue surrounding the original tumor and is completed in five days.

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