|AeroForm Tissue Expander--Courtesy of AirXpanders|
AirXpanders announced that the pivotal trial of its AeroForm Tissue Expander met its primary endpoint in women who seek a permanent breast implant following a mastectomy.
A rare clinical trial for a 510(k) submission, the trial is designed to compare the safety and efficacy of the device to standard saline expanders. The study involved 150 patients across 17 sites in the U.S.
The primary endpoint was "successful tissue expansion and exchange to a permanent breast implant unless precluded by a non-device related event," according to ClinicalTrials.Gov. In addition, AirXpanders said the device demonstrated the same safety profile as saline tissue expanders. Additional details will be presented at the American Society of Plastic Surgeons Meeting in Boston on Oct. 18.
Approved in Europe and Australia, the AeroForm is implanted behind the chest muscle and expands to help tissue take the shape of a breast thanks to carbon dioxide delivered through an internal valve. The gas is released from within the device's silicon shell at the command of the patient via wireless remote control. Traditional tissue expanders involve the injection of a saline solution.
"AeroForm has demonstrated that it can be used as effectively as saline expanders in the treatment of women who are going through two-stage reconstructive surgery following a mastectomy. I am looking forward to being able to offer this option to my patients and believe that this device has the potential to be the new gold standard for women who are recovering their shape following breast cancer surgery," said the trial's principal investigator, Dr. Jeffrey Ascherman, the chief of plastic surgery at the Columbia Presbyterian Medical Center in New York.
AirXpanders believes the market size for AeroForm is 120,000 units per year out of an addressable market of 350,000 units per year, at least in the U.S. The company plans a commercial launch immediately after obtaining 510(k) clearance from the FDA.
AirXpanders says advantages of AeroForm over saline-filled expanders include a shorter recovery time of about 17 days and the use of compressed gas--released at the discretion of the patient via remote control--rather than the injection of a saline solution.
The Silicon Valley company debuted on the Australian Securities Exchange earlier this year. It aimed to raise AU$36.5 million ($26 million) through the IPO.
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