FDA Clears Andrew Tech. Lipoplasty System

Commercialization of the HydraSolve Begins in Early 2013

December 18, 2012
Manufacturing Group
Assembly Materials Quality/Metrology People/Facilities

Andrew Technologies LLC received FDA 510 (k) clearance for the commercially manufactured version of the HydraSolve Lipoplasty System, having successfully completed design verification and validation of that device versus the previously cleared prototype device.

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 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 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 not damaging or cutting blood vessels, nerves or connective tissue. HydraSolve achieves liquefaction of fat tissue by cell disaggregation, not by the lysing of cell membranes. Andrew Technologies has a patent for the HydraSolve Lipoplasty System through 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 of the research and development of HydraSolve. According to Dr. Andrew, "HydraSolve is the first non-cutting liposuction device, it offers a target-tissue specific method to remove fat tissue and only fat tissue so that collateral damage to non-targeted tissues is reduced and minimized, with the intention of shortening the patient's post-op recovery period and minimizing his or her pain, swelling and bruising. Additionally, HydraSolve provides excellent control and precision in removing fat tissue for surgeons, and it also reduces their physical exertion."

"The HydraSolve system was invented by Andrew Technologies in close collaboration with three U.S.-based strategic suppliers.  This allowed for an optimal development cycle of the third generation design to better address the clinical needs of users," stated Stephane Gobron, VP Product Development. Andrew Technologies will complete the manufacturing of the initial launch devices and will begin commercialization with a selective launch to pre-identified expert 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 intends to expand the launch nationally by mid-2013 and to begin rest of world distribution in 2014.

According to the International Society of Aesthetic Plastic Surgery over 2,000,000 liposuction procedures are conducted annually across the globe. "The advantages of HydraSolve offer the potential for Andrew Technologies to capture a significant share of that market; and to potentially expand the overall demand for liposuction, given its excellent consumer resonance and gentle effect on patients," states Tom Albright, CEO of Andrew Technologies.