Brava System Used In New Study

The Brava System, the only clinically proven device for non-surgical breast augmentation, is part of a leading edge study that offers women a new minimally invasive option for breast augmentation and reconstruction. The study, "Breast Augmentation With Grafting of Liposuctioned Fat: A Safe and Effective Procedure," is being conducted by Roger K. Khouri, M.D., Steven E. Chavoustie, M.D. and Macarena Carretero, M.D. The preliminary findings will be presented today at the American College of Obstetricians and Gynecologists (ACOG) 55th Annual Clinical Meeting in San Diego. Until now, women have had two clinically-proven options available for breast augmentation: surgical breast implants and a non-surgical enhancement through the use of an external tissue expansion device. In this study, physicians utilize autologous fat to reshape and augment the breasts.

Historically, autologous fat injection in breast augmentation was controversial and banned in 1987 by the American Society of Plastic and Reconstructive Surgeon's Ad-Hoc Committee on New Procedures. The Committee's opinion stipulated that much of the injected fat would not survive and the physiologic response to fat necrosis was scarring and calcification, thus making mammography difficult to interpret. Today, with advancements in breast imaging, the harvesting of tissue, more refined surgical cannulas and improved preparation of the recipient graft site, this procedure is now a viable option for breast augmentation. For this procedure, patients are treated pre-operatively and post-operatively using Brava, an external tissue expander, to prepare, and later stent, the recipient site. The single-stage, large-volume lipotransfer breast augmentation notes a graft survival rate of 90% in the prepared, expanded, hypervascularized tissue bed. While the study is on-going, the 25 reported patients who have gone through the process have had increases of between 90 to 300 ml per breast (approximately 1 to 2-1/2 cup sizes). "OB/GYNs are frequently asked by their patients about breast augmentation and reconstruction", says Dr. Chavoustie. "Traditionally, there were only two alternatives we could offer our patients, breast implant surgery or a non-surgical breast expansion device. Now, this new procedure, which is both safe and effective, offers the benefit of a natural (autologous) fat filler, which will not affect breast imaging, and has the added benefit of target site liposuctioning. Dr. Chavoustie goes on to explain, "Not only are we looking at this new cutting edge procedure as a cosmetic alternative, but also for future reconstructive applications for patients with status-post lumpectomy filling defects or breast asymmetry."

Dr. Steven Chavoustie, Physician Director of Research and Development at Brava, LLC, will be present at the ACOG's Annual Clinical Meeting, Poster Presentation #98, to discuss the study in more detail on Tuesday afternoon, May 8th. He will also be available at booth #436 (Brava, LLC) Monday, May 7th and Wednesday, May 9th.

For more information about the Brava System, please visit the Brava Web site,
www.brava.com

About the Study Investigators

Roger K. Khouri, M.D., is a noted plastic and reconstructive surgeon practicing in Miami, FL and the inventor of the Brava System. Prior to co-founding Brava, LLC, Dr. Khouri held professional and fellowship positions at Brown, Harvard, New York and Washington Universities.

Steven E. Chavoustie, M.D., FACOG, is the Physician Director of Medical Research and Development at Brava, LLC and a Voluntary Assistant Professor of Obstetrics and Gynecology and Medical Education at the University of Miami, Miller School of Medicine.

Macarena Carretero, M.D., is a practicing radiologist and co-director at the Breast Health Center in South Miami, FL, and has served over 20 years as a member of the American Society of Breast Disease.

About Brava, LLC

Brava, LLC, founded in 1999, is a medical device manufacturer. Products include the Brava Breast Enhancement System. Brava, LLC headquarters are located at 14221 S.W. 142nd Street, Miami, FL 33186.

Brava, LLC
www.brava.com

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