In short
Andrew Technologies, LLC has gained the first FDA 510 (k) clearance for Autologous Fat Transfer. This means that adipose tissue harvested during a HydraSolve liposuction procedure can be reinjected into the same patient for rejuvenation or augmentation.
Background
We’ve covered HydraSolve before, most notably last December when it was cleared for lipoplasty.
HydraSolve is a novel liposuction device, combining natural saline solution with low levels of pressure and temperature, to liquefy only targeted fat tissue. The energized saline stream, inside the cannula, 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.
The new clearance is clearly adjunctive to the original and means tissue harvested from the patient can be used for cosmetic purposes in that same patient.
Physician comments
Dr. Bruce Van Natta, a plastic surgeon with Meridian Plastic Surgeons in Indianapolis 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.”
Company comments
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.”
Tom Albright, CEO of Andrew Technologies says; “We are thrilled to achieve our second FDA clearance in less than 6 months. As a start-up 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 tissue for transfer.”
Source: Andrew Technologies, LLC, PR Newswire