Orlando Clinic in FDA Breast Enhancement System Study
Bougainvillea Clinique is one of only five locations, nationwide, invited to continue participating in an FDA study utilizing fat grafting with a breast enlargement device.
Orlando, FL (PRWEB) May 15, 2013
A local medical center is one of only five locations, nationwide, invited to continue participating in an FDA study utilizing fat grafting with a breast enlargement device. The FDA previously approved the BRAVA®, which grows a woman´s natural breast tissue without surgery, pills or creams for breast enlargement. Now the new fat grafting study hopes to expand the FDA´s approval of the BRAVA device.
Located at 4355 Bear Gully Rd. in Winter Park, Fla., The Bougainvillea Clinique and the Aesthetic Surgery Center of Winter Park, are pioneering the virtually scarless breast reconstruction procedure with this study as well as by offering a system to liquefy only targeted fat for the fat grafting procedure, leading to a cleaner and purer fat for grafting. The Bougainvillea Clinique is Central Florida´s only clinic using the HydraSolve Lipoplasty System from Andrew Technologies, which is FDA-approved.
For the BRAVA device, the Bougainvillea Clinique, led by Dr. Jeffrey Hartog, is a co-investigator site for the remainder of a study seeking full FDA approval. This approval will allow the entire procedure, intended for breast cancer patients needing reconstruction, to be covered by insurance.
The study, titled “Breast Reconstruction and Augmentation with BRAVA-Enhanced Autologous Fat Micrografting,” seeks to document the safety and efficacy of using the BRAVA system with fat grafting.
“This is an important milestone in the advancement of fat grafting breast reconstruction and augmentation,” Hartog said. “The Bougainvillea Clinique is dedicated to helping those who´ve battled breast cancer, and women who want to improve the look and feel of their breasts, by using the fat grafting technique. Adding the BRAVA technique to the fat grafting could lead to additional results for women.”
The FDA also approved the BRAVA device as a Medicare-reimbursable Category B device. Thus far, the BRAVA device has shown an impressive safety record for the more than 600 patients who have participated in the study.
Using fat grafting with BRAVA will offer more options to women who seek a natural, scarless breast reconstruction and augmentation.
Hartog is a leader in the field of fat grafting with an adjacent free-standing state- and federally licensed surgical center within the Bougainvillea Clinique that caters to all client needs. This surgical center, The Aesthetic Surgery Center of Winter Park, is a state-licensed and Medicare-certified ambulatory surgery center. The surgery center is licensed by the Florida Agency for Health Care Administration. The Bougainvillea Clinique is the only plastic surgery office in the Greater Orlando area that provides this level of certification immediately adjacent to its office.
About Bougainvillea Clinique
Located in Central Florida, the Bougainvillea Clinique is a premier destination for people who want to look and feel their best. Jeffrey M. Hartog, M.D., and Michelle Hartog, R.N., established the Bougainvillea Clinique with the goal of improving people´s quality of life through state-of-the-art cosmetic treatments. The Bougainvillea Clinique is the first plastic surgery facility in the U.S. to offer the Liquid Gold fat-banking approach and one of the few U.S. facilities with the Cytori StemSource® device for separation of adult stem and regenerative cells from fat. For more information, visit http://www.lookandfeelbetter.com or call 866-985-4741.
For the original version on PRWeb visit: http://www.prweb.com/releases/prweb2013/5/prweb10733223.htm