Peer-reviewed study published in Plastic and Reconstructive Surgery says device could “offer a new paradigm in breast reconstruction”
PALO ALTO, Calif. (October, 2011) – AirXpanders Inc., a company developing technology to address current unmet needs for patients who require tissue expansion for reconstructive surgery, today announced new published data show that its AeroForm™ breast tissue expansion device has the potential to improve patient experiences for women having their breast(s) reconstructed after a mastectomy. The study was published online in Plastic and Reconstructive Surgery, the journal of the American Society of Plastic Surgeons and serves as the basis for the company’s larger confirmatory trial in the U.S.
“The AeroForm may offer a new paradigm in breast reconstruction,” said Dr. Anthony Connell, FRACS, Mount Hospital, the study’s lead author. “In eliminating weekly office visits to receive bolus needle inflations or percutaneous component, the AeroForm’s self-contained carbon dioxide reservoir has demonstrated the possibility for a number of advantages over saline injections, which may be confirmed by future studies. With these new benefits, we hope that the approximately 75% of women who opt to forego reconstruction may reconsider their decision.”
The study showed that needle-free nature of an AeroForm expansion can reduce discomfort and potentially reduce infection rates. Additionally, by enabling patients to optimize their own expansion rates, the average time needed by patients in the study to reach full expansion was 13 days, a fraction of that required by traditional methods. The study was a prospective, open-label, single-site, single-arm feasibility clinical study in an urban university hospital setting in Perth, Australia, enrolling seven patients.
Currently, when a mastectomy patient wishes to undergo breast reconstruction, the method most often used is expansion followed by implantation. The traditional method is for a surgeon to implant a saline tissue expander under the skin and pectoral muscle at the site of the mastectomy. During subsequent weekly office visits, which can last for more than 22 weeks, the surgeon will insert a needle through the skin into the tissue expander’s port and inject as much saline into the temporary implant as the woman can tolerate
“We understand the need for more effective tissue expansion technologies and are extremely pleased that the patients in this pilot study had such positive experiences and outcomes with AeroForm,” said Scott Dodson, AirXpanders President and Chief Executive Officer. “We are diligently working with leading medical centers in the U.S. to confirm these positive results in the head-to-head PACE study.”
The company is currently enrolling 138 U.S. patients into a study known as XPAND to confirm these results in a larger patient population. The company is actively working with institutional review boards (IRBs) at 10 leading U.S. hospitals and plans to enroll the first patient in the prospective, randomized, controlled, open-label pivotal study shortly. The results of the study will be the basis for the company’s 510(k) application, seeking clearance in the U.S.
AirXpanders designed the AeroForm tissue expander to address the limitations of traditional saline expanders. The system consists of a technologically advanced self-contained tissue expander and a small hand-held wireless remote control. The AeroForm system uses compressed carbon dioxide that is gradually released through a small internal valve, in place of invasive saline injections, to fill the expander. Following a standard procedure to implant the expander, the patient can use the remote control at home to perform the expansion process as directed by the surgeon.
Hospitals in Atlanta, Boston, New York, St. Louis, San Diego and other cities across the U.S. are participating in the XPAND study. For more information on the study, please visit www.clinicaltrials.gov and search “XPAND”.
AirXpanders Inc. 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 recovering one’s body shape after cancer can potentially be eased with this needle-free technology that is easy to use and may enable the patient to proceed to a permanent implant much faster than current standard-of-care allows. At this time, AirXpanders’ products are not cleared or approved for sale. AirXpanders is backed by GBS Venture Partners, Prolog Ventures, Heron Capital and Shalon Ventures.
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