UltraShape Ltd. announced that the US Food and Drug Administration advised the company that it may submit a request for clearance of its Contour I system under the 510(k) regulation rather than as a Pre-Market Approval (PMA) as was previously advised.
Proceeding under the 510(k) pathway is expected to simplify and shorten the submission process to the FDA for clearance to sell the Company's Contour I system in the United States.
The UltraShape? Contour I system provides non-invasive body contouring using focused ultrasound to reduce the appearance of spotty fat deposits. During treatment, fat cells are targeted while important surrounding structures such as skin, blood vessels, nerves and connecting tissues remain unharmed. Featured in May's O Magazine, UltraShape requires no down time nor recovery period so that you can go straight back to work.
Developers launched a new machine, the Contour I ver3, in January of this year. Featuring a multi-application platform, this device added the RFVac accessory that enables physicians to combine both radio frequency and vacuum capabilities improving the effectiveness and consistency of the results. The RFVac prepares the tissue before the ultrasound treatment and accelerates the clearance of fat following the treatment, all in a single session avoiding the need to switch machines mid-treatment.
The treatment is currently cleared for use in 57 countries, and patients report that sessions are relatively painless. According to O Magazine, Canadian dermatologist Dr. Mark Lupin says patients report, "just a slight tingly sensation." Patients typically undergo three treatments, spaced two weeks apart, and are able to see results about a month after each. "On average, patients ultimately see about a two-inch reduction in circumference in the treated area," said Dr. Lupin. "And we've seen as much as three inches."
Recent Peer-Reviewed Data Support Unique Focused Ultrasound Technology for Non-Invasive Fat Reduction and Body Contouring
Earlier this year the company announced UltraShape's basic science and pre-clinical research demonstrating proven tissue effects.
The publication by S. Brown, PhD et al entitled "Characterization of Non-thermal Focused Ultrasound for Non-invasive Selective Fat Cell Disruption (lysis): Technical and Pre-clinical Assessment" is currently available on PRS Advance Online at http://www.plasreconsurg.com, the Website for Plastic and Reconstructive Surgery, the Journal of the American Society of Plastic Surgeons.
"This extensive research confirms that the UltraShape Contour I system is the first non-invasive technology to produce a non-thermal focused acoustic field at a controlled subcutaneous target resulting in stable cavitation," said Spencer Brown, PhD, Director of Research, Plastic Surgery Department at the University of Texas Southwestern Medical Center, and member of the UltraShape Medical Advisory Board.
"Histopathologist reviewed specimens of dermal and sub-dermal tissue, including subcutaneous fat, demonstrated selective fat cell destruction with preservation of surrounding critical structures such as skin, blood vessels, nerves and connective tissue. No epidermal or dermal changes were observed clinically or histologically."
UltraShape has always taken the high road and based their claims on science and sound research.
This published research demonstrates a well-understood mechanism of action with proven tissue effects, said Jeffery M. Kenkel, M.D., F.A.C.S., Vice Chairman and Professor of Plastic Surgery at the University of Texas Southwestern Medical Center, and Chairman, UltraShape Medical Advisory Board.
"UltraShape is the first non-invasive aesthetic technology to be scientifically validated by such comprehensive pre-clinical research."
The publication of our extensive scientific and pre-clinical research in plastic surgery's premier peer-reviewed journal is yet another significant milestone for our company.
About the UltraShape Contour I
The UltraShape Contour I system, which is authorized for marketing outside the U.S., incorporates patented non-thermal selective focused ultrasound technology. Contour I, is the first scientifically and clinically proven non-invasive fat reduction and body contouring device for both men and women.
The device is designed to produce mechanical, non-thermal, acoustic effects which target and selectively disrupt fat cells, leaving surrounding critical structures such as:
The UltraShape procedure is available in 57 countries and over 100,000 patient treatments have been performed worldwide with high patient satisfaction.
- Blood Vessels
- Nerves and connective tissue intact
The UltraShape procedure is guided by proprietary real-time tracking and guidance technology designed to deliver smooth, uniform body contouring results.
The software provides a pre-determined treatment algorithm designed to minimize risk of contour irregularities, a common side effect of liposuction.
The UltraShape procedure is performed during a convenient, "walk-in, walk-out" session carried out in an office-based environment; it requires no anesthesia or sedation.
After treatment, patients immediately resume their daily routines with no need for maintenance treatments.
The UltraShape Contour I received the CE Mark in 2005 and a medical device license from Health Canada in 2007.
The Contour I system is not available for sale in the U.S. and the Contour Plus system is an investigational product limited by U.S. law to investigational use only.