Syneron Medical Ltd., a leading global aesthetic device company, announced today that the PicoWay® picosecond laser received U.S. Food and Drug Administration (FDA) clearance for a new ultra-short 785nm wavelength, which is the third FDA cleared wavelength for PicoWay. The new ultra-short 785nm wavelength is the first of its kind in the aesthetic market, utilizing a titanium sapphire laser for the removal of blue and green inks, and will be available to new and existing PicoWay customers in the U.S. market in the fourth quarter 2016.
The FDA clearance of the new ultra-short 785nm wavelength was supported by a 15 patient study, covering 22 tattoos, of which 18 contained blue and green inks. Blinded evaluation of tattoo clearance, by independent board-certified physicians, showed that 83% of the treated blue/green tattoos had “good” to “complete” treatment response after 2 PicoWay treatments with the 785nm wavelength. Moreover, investigator assessments of tattoo clearance showed similar results to blinded evaluation findings. There were no treatment complications, and PicoWay treatments were generally associated with no discomfort to mild discomfort for the majority of treatments.
Eric F. Bernstein, MD, MSE, Director of the Main Line Center for Laser Surgery in suburban Philadelphia, PA, and Chairman of the Candela Laser Corporation Medical Advisory Board, was the principal investigator for the clinical study resulting in FDA clearance of the new 785nm wavelength for PicoWay laser. Dr. Bernstein commented, “This is the first, ever, 785nm wavelength picosecond-domain laser in the world. This novel addition to the PicoWay enables optimal treatment for blue and green tattoos, and is a welcome addition to the 532 and 1,064nm wavelengths already available with the PicoWay. I am extremely impressed with Jay Bhawalkar and his engineering team at Candela, who developed the PicoWay. The new 785nm wavelength further enhances the already strong capabilities of the PicoWay platform for tattoo removal, adding to its ability to rapidly and safely clear multicolored tattoos. I am thrilled to offer this new wavelength to my patients, and honored to have lead the clinical trial leading to FDA clearance of the PicoWay and this new wavelength.”
The innovative PicoWay laser platform delivers ultra-short pulses of energy (e.g., 300 picoseconds at 785nm) making treatments shorter and comfortable for patients while offering the industry's shortest pulses and highest peak power. The addition of PicoWay's third wavelength completes the PicoWay laser platform, allowing for the comprehensive removal and treatment of all colors of tattoos and pigmented lesions. The PicoWay picosecond laser previously received FDA clearance for the removal of tattoos in November 2014 and the treatment of pigmented lesions in April 2015.
Amit Meridor, Chief Executive Officer of Syneron Medical, said, “We are pleased to receive FDA clearance for the new 785nm wavelength for PicoWay, which enhances its ability to remove blue and green tattoo ink. With the addition of this third wavelength, PicoWay can now provide practices with the ability to provide comprehensive removal and treatment of all colors of tattoos and skin pigmentation. We look forward to making this feature available to new and existing PicoWay customers in the U.S. beginning in the fourth quarter.”
Source : investors.syneron.com