Bovie Medical (NYSE:BVX) said today it launched an FDA investigational device exemption clinical study of its J-Plasma surgical cutter, looking to explore the use of the device in dermal skin resurfacing.
The first patient in the trial was enrolled by Dr. J. Holcomb at Sarasota, Fla.’s Institute for Integrated Aesthetics.
The J-Plasma device is a plasma-based cutter and coagulator that uses helium ionization to produce a focused beam of ionized gas over a blade, used for cutting or coagulating during surgeries, the Clearwater, Fla.-based company said.
In its newly launched multi-center, single arm, evaluator-blind prospective study, Bovie Medical aims to evaluate the safety and efficacy of the J-Plasma system for reducing facial wrinkles and rhytides. The study is looking to enroll 55 patients at five centers, and each patient will receive one procedure with the J-Plasma system.
Results for wrinkle severity will be assessed using the Fitzpatrick Wrinkle and Elastosis Scale at baseline and at each follow-up time point.
“At Bovie Medical, our long-term clinical strategy is focused on expanding J-Plasma’s clinical indications for use in the aesthetics market, beginning with dermal skin resurfacing procedures. Enrolling the first patient in our dermal skin resurfacing clinical study is an important milestone towards this long-term strategy. The company intends to use data from this study to demonstrate the safety and efficacy of our J-Plasma technology to support our planned 510(k) submission to the U.S. Food and Drug Administration for an indication to market and sell J-Plasma for use in dermal resurfacing procedures,” CEO Charlie Goodwin said in a press release.
Last February, Bovie Medical saw shares plummet after it announced it did not extend the sales channel partnership with Hologic (NSDQ:HOLX) for its J-Plasma product.
The post Bovie Medical launches IDE J-Plasma dermal skin resurfacing study appeared first on MassDevice.
from MassDevice http://ift.tt/2Gf1ukk
Cap comentari:
Publica un comentari a l'entrada