PALO ALTO, Calif., April 14, 2015 /PRNewswire/ -- AirXpanders Inc., a company developing novel technology for women who require tissue expansion for breast reconstruction following a mastectomy, today announced that it has completed the targeted enrollment of 150 subjects in the company's U.S.-based, multi-center, prospective, randomized, controlled, open-label pivotal study of the AeroForm® patient-controlled tissue expander.
The XPAND study was designed to directly compare outcomes in two-stage breast reconstruction – including successful expansion to implant exchange, average number of days to achieve the desired expansion, total reconstruction time, pain and patient satisfaction – with AeroForm versus traditional saline expanders. The traditional method for tissue expansion requires women to visit their physician for frequent injections of saline until they complete the process, which can take up to six months as reported in the literature.
"Today, only around 30-40 percent of women who have had a mastectomy undergo reconstruction, as many women are not aware of their reconstruction options. Some candidates for reconstructive surgery say that the reported long and sometimes painful saline-based expansion process kept them from pursuing that option," said XPAND Principal Investigator Jeffrey Ascherman, M.D., FACS, site chief of the Division of Plastic Surgery at New York-Presbyterian Hospital/Columbia University Medical Center. "Eliminating some of the office visits required to inflate saline expanders by needle injections is a definite advantage of the new expander over the traditional process. My patients have also appreciated the opportunity to play an active role in recovering their bodies after breast cancer surgery."
In an interim preliminary review of study data, as reported in the May 2014 edition of the Annals of Plastic Surgery, Kamakshi Zeidler, M.D., FACS at Good Samaritan Hospital in San Jose, California reported that 115 patients were enrolled in the XPAND study and randomized to either the AeroForm or saline group. The group who received the AeroForm patient-controlled expanders completed expansion in an average of 17 days, compared with the saline group whose expansion process extended an average of 52 days (P<0.0001). Dr. Ascherman reported similar results in his publication in the October 2014 issue of the Plastic and Reconstructive Surgery Journal.
At the completion of study enrollment, a total of 98 women were implanted with AeroForm expanders and 52 women with saline expanders. Over 70 percent of women in the trial had bilateral procedures. The women who received AeroForm expanders used a wireless remote control to trigger the release of small, regulated amounts of carbon dioxide to fill the tissue expander, according to a protocol directed by their physician. Once the tissue was adequately expanded, the women returned to have their expanders removed and a standard breast implant placed.
"Completing the enrollment of the primary phase of the XPAND study represents a major milestone for AirXpanders. We are currently focused on following up with the patients, ensuring we have the proper mix of subjects in each group, and completing our 510(k) filing, which we plan to submit to the U.S. Food and Drug Administration very soon. Simultaneously, we have initiated commercial sales of AeroForm in Australia and plan to support a full launch later this year," said Scott Dodson, president and chief executive officer of AirXpanders. "We are extremely pleased to see consistent results in all of the trials that have been conducted around the world. Preliminary results from the XPAND study indicate positive patient experiences, significantly faster expansion times and decreased time to complete the reconstruction process with the AeroForm expander compared with traditional saline devices. There is every reason to believe that the AeroForm technology will become the new standard of care for all two-stage reconstruction procedures."
AirXpanders Inc. (www.airxpanders.com) is a tissue expansion company focused on the area of breast reconstruction. By employing a revolutionary patient-controlled expander, activated by a wireless remote control, the often painful process of reclaiming one's body after cancer can potentially be eased with this needle-free technology. This technology is easy to use and may enable the patient to proceed to a permanent implant much faster than the current standard of care. At this time, AirXpanders' products are not cleared or approved for sale. AirXpanders is backed by Vivo Ventures, GBS Venture Partners, Prolog Ventures, Heron Capital, Shalon Ventures, Correlation Ventures and Western Technology Investments.
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