Andrew Technologies, Inc. Receives FDA 510(k) Clearance for Autologous Fat Transfer With HydraSolve Lipoplasty System
4/24/2013 7:44:14 AM
IRVINE, Calif., April 24, 2013 /PRNewswire/ -- Andrew Technologies, LLC received FDA 510 (k) clearance for Autologous Fat Transfer, so that the adipose tissue (fat) harvested during a HydraSolve liposuction procedure can be reinjected into the same patient for rejuvenation or augmentation. No other liposuction device has been FDA cleared for this use.
HydraSolve is a novel liposuction device based on the same patented Tissue Liquefaction Technology that was launched in 2003 by Alcon as the AquaLase® Liquefaction Device, a modality on the Infiniti Vision System, for precision cataract surgery. Hydrasolve combines natural saline solution with low levels of pressure and temperature, to liquefy only targeted fat tissue. Because fat tissue is liquefied, the cutting of fat by forceful thrusts of the cannula is no longer required. The specially designed HydraSolve cannula is also manufactured with aperture edges that have a rounded radius of curvature that do not cut tissue. It is the energized saline stream, inside the cannula, that liquefies targeted fat tissue while preserving blood vessels, nerves and connective tissue integrity. HydraSolve achieves liquefaction of fat tissue by cell disaggregation, not by emulsification and the lysing of cell membranes.
Dr. Mark S. Andrew, Chief Scientific Officer of Andrew Technologies stated, "We are extremely pleased to take a leading role in providing technology for autologous fat grafting that we believe can improve the process for the surgeon and the outcome for the patient." Dr. Bruce Van Natta, a plastic surgeon with Meridian Plastic Surgeons in Indianapolishttp://www.indyplastic.com/ is part of the Expert Release program for HydraSolve and has treated several patients since March, added "I have found that HydraSolve rapidly removes fat and produces a nearly bloodless fat layer of uniform particles that can be easily injected into breasts and other target tissues. It may be the best system I have used for autologous fat grafting."
Tom Albright, CEO of Andrew Technologies says; "We are thrilled to achieve our second FDA clearance in less than 6 months, as a startup medical device company that is quite an accomplishment. Also since autologous fat grafting is a major focus for aesthetic medicine, we are pleased to offer our surgeons the first liposuction device that is FDA cleared for the harvesting of adipose (fat) tissue for transfer."
About Andrew Technologies, LLC
Andrew Technologies www.hydrasolve.com, founded in 2007 by Mark S. Andrew, M.D., is a medical technology company committed to improving patients' lives through body aesthetics and the pursuit of surgical applications of Tissue Liquefaction Technology. Andrew Technologies is a venture capital funded company based in Orange County, CA and Haddonfield, NJ. Our primary investors are WFD Ventures www.wfdventures.com and NJTC Venture Fund www.njtcvc.com.
SOURCE Andrew Technologies, LLC