IRVINE, CA., December 17, 2012 /PRNewswire/ — Andrew Technologies, LLC has received FDA 510 (k) clearance for the commercially manufactured version of the HydraSolve™ Lipoplasty System, having successfully completed design verification and validation of this device against the previously approved prototype device.
HydraSolve™ is a new liposuction device based on the same patented Tissue Liquefaction Technology™ launched in 2003 by Alcon as the AquaLase® liquefaction device for precision cataract surgery. HydraSolve™ combines natural saline solution with low levels of pressure and temperature to liquefy only the targeted fatty tissue. Because the adipose tissue is liquefied, it is no longer necessary to cut the fat with strong thrusts of the cannula. The specially designed HydraSolve™ cannula is manufactured with opening tips that have a rounded radius of curvature that does not cut tissue. It is the activated saline stream, inside the cannula, that liquefies the targeted fatty tissue while not damaging or cutting blood vessels, nerves or connective tissue. HydraSolve™ achieves fat tissue liquefaction by cell disruption, not cell membrane lysis. Andrew Technologies holds a patent for the HydraSolve™ Liposuction System until 2028.
Dr. Mark S. Andrew, who co-invented HydraSolve™ and related technologies, is now Chief Scientific Officer of Andrew Technologies and has been directly involved in all HydraSolve™ research and development. According to Dr. Andrew, “HydraSolve™ is the first non-incisional liposuction device, it offers a target tissue specific method to remove adipose tissue and only adipose tissue so that collateral damage to non-targeted tissues is reduced and minimized , with the intention of shortening the patient’s postoperative recovery period and minimizing his or her pain, swelling and bruising.In addition, HydraSolve™ provides excellent control and precision in fat removal for surgeons and also reduces their physical strain ».
“The HydraSolve™ system was developed by Andrew Technologies in close collaboration with three strategic US-based suppliers. This enabled an optimal development cycle of the third-generation design to better address the clinical needs of users,” he said. Stephane Gobron, Vice President of Product Development. Andrew Technologies will complete manufacturing of the initial launch devices and begin commercialization with a selective launch to pre-specified specialist plastic surgeons in the United States in early 2013. These expert plastic surgeons will generate clinical data that will be used to quantify the benefits of HydraSolve™ to be used in future communication with surgeons and with patients seeking aesthetic body contouring. The company plans to expand the rollout nationwide by mid-2013 and begin distribution to the rest of the world in 2014.
According to the International Society of Aesthetic Plastic Surgery, more than 2,000,000 liposuction procedures are performed annually worldwide. “The advantages of HydraSolve™ offer Andrew Technologies the opportunity to capture a significant share of this market and potentially expand the overall demand for liposuction, given its excellent consumer appeal and gentle effect on patients,” he said. Tom AlbrightCEO of Andrew Technologies.
About Andrew Technologies, LLC
Founded in 2007, Andrew Technologies is a medical technology company committed to improving patients’ lives through body aesthetics. Andrew Technologies is a venture capital funded company that will be headquartered in Orange County, CA. Our lead investors are WFD Ventures and the New Jersey Technology Council.
SOURCE Andrew Technologies, LLC