Pelleve Receives FDA Clearance for the Treatment of Mild to Moderate Facial Wrinkles
Ellman International launches next-generation aesthetic skin tightening technology
"Today's FDA clearance of the Pelleve system represents a very exciting step in the introduction of next-generation high frequency radiowave technology to physicians and patients in
Pelleve uses the advanced radiowave technology of the Ellman International Surgitron(R) Dual RF(TM) S5 and a proprietary Pelleve handpiece to precisely deliver energy through the skin to the dermal tissue beneath without damaging the epidermis. This gentle heating of the deeper dermal tissue induces collagen denaturization and contraction. As the dermal tissue recovers, new collagen synthesis occurs, which creates a tightening effect. The result is a noticeable improvement in skin quality and appearance with minimal side effects and healing time for patients.
In a clinical trial conducted to determine the effectiveness of the Pelleve system, 83 women and 10 men were given a single treatment with the Pelleve handpiece. The procedure was performed in an ambulatory (outpatient) setting with no need for skin cooling products or anesthesia and took an average of 15 to 20 minutes, depending on size of the area. More than 87% of patients showed measurable and immediate positive results in a blinded assessment of skin laxity and wrinkle improvement with continued response at six months after treatment. Patients were typically able to return to work and social activities immediately after treatment. Of the study population, two patients experienced small abrasions that healed within three days.
"Our research clearly demonstrates the power of the Pelleve Skin Tightening System. With a single Pelleve treatment, over 87% of our patients experienced an improvement in skin laxity and fewer overall facial wrinkles at six months. The Pelleve Skin Tightening System is an effective, non-invasive, economical and safe tool," said Dr.
Ellman's skin tightening technology has been marketed with a CE Mark in many countries since 2005 under the name Radiage. "We have seen positive results in many patients outside of
Designed to work in conjunction with the Surgitron Dual RF S5 platform, Ellman's patented 4.0 MHz radiowave unit, Pelleve handpieces represent just one of hundreds of accessories available for office and clinic environments. The Surgitron Dual RF S5 provides maximum control in precision cutting and energy delivery, with more versatility than other energy-based technologies. "Ellman's proven product platform enables medical professionals to perform surgical procedures that produce less tissue damage and pain than the competition. Adding Pelleve offers tremendous value to physicians, as customers ask for the latest in cosmetic correction from their dermatologists, plastic surgeons and other healthcare professionals," said Epstein. Pelleve will be introduced to the U.S. market this month through dermatologists, plastic surgeons, ENTs and other cosmetic surgery clinics.
For more information about Pelleve and the Surgitron Dual RF S5 system or to locate doctors using this unique high radiofrequency technology, visit www.pelleve.com or call 1-800-835-5535.
About Ellman International
Established in 1959, Ellman International (
SOURCE Ellman International, Inc.