Tissue Expansion Traditionally Considered One of the Most Painful Aspects of Breast Reconstruction
Full Results of Australian PACE-2 Study Presented at Plastic Surgery 2013
PALO ALTO, Calif., Oct. 15, 2013 (GLOBE NEWSWIRE) -- AirXpanders Inc., a company developing novel technology for women who require tissue expansion for breast reconstruction following a mastectomy, today reported the full results of the PACE-2 (Patient Activated Controlled Expansion) trial of its AeroForm™ device.
The AeroForm is an injection-free, patient-controlled tissue expansion system under investigation in the United States and Australia, where the PACE-2 study was conducted. The 40 patients in the study completed their expansion within an average of 17 days, consistent with all other published results of AeroForm studies to date. Traditional saline expansion requires women to visit their physician for frequent injections until they complete the process, which can take up to six months.
Thirty-three of the 40 subjects in the study did not complain of pain post-procedure. Of the seven subjects reporting pain (7/40, 17.5%), six described their pain as mild-to-moderate and one subject (1/40, 2.5%) described her pain as severe. Thirty-one subjects found the device very easy to use and all 32 respondents were satisfied with the results.
"Traditionally, tissue expansion following a mastectomy is one of the most tedious and painful processes of breast reconstruction. To achieve expansion in 17 days on average and for the vast majority of the patients to report only mild-to-moderate or no pain throughout the expansion process is extremely compelling, and further supports AeroForm as an exciting, much-needed innovation in breast reconstruction," said Anthony Connell, FRACS, plastic surgeon in Perth, Australia and principal investigator of the PACE-2 trial. "Patient-controlled expansion, where women are able to expand at their own pace and level of comfort, offers mastectomy patients a less painful, more convenient option for expansion – and a chance to regain control over their body during a time in which much is out of their control."
The new qualitative data were presented at Plastic Surgery 2013, the annual meeting of the American Society of Plastic Surgeons (ASPS) and the Plastic Surgery Foundation taking place October 11 to 15 in San Diego.
Dr. Connell presented the data from the 40 patients enrolled in the prospective, open-label, single-arm, feasibility trial. Thirty-one patients underwent bilateral mastectomies and received tissue expanders in both breasts, while the remaining nine patients underwent unilateral replacement. To date, the study includes 71 patient-controlled expanders, all of which were expanded to and maintained clinically desired breast volume until permanent implant. No device-related adverse events were reported.
"We are extremely pleased to see consistent, similar results in the PACE trial. Results continue to show positive patient experiences, significantly faster expansion times and less pain with the AeroForm expander compared to traditional saline expanders," said Scott Dodson, AirXpanders President and Chief Executive Officer. "We are diligently working towards regulatory submission in Australia and a subsequent limited market release slotted for April 2014. In the U.S., enrollment in the ongoing XPAND study is nearly complete and we expect to announce the close of the trial by the end of 2013."
AirXpanders Inc. (www.airxpanders.com), is a tissue-expansion company focused on the area of breast cancer 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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