AirXpanders Announces First Patient Treated in IDE Trial of New Post-Mastectomy Tissue Expansion Device
The XPAND trial will evaluate AeroForm™ as a possible alternative to standard tissue expansion in breast reconstruction process PALO ALTO, Calif. – December 5, 2011 – AirXpanders Inc., a company developing technology to address current unmet needs for patients who require tissue expansion for breast reconstruction surgery, today announced that the first patient has been treated in the XPAND (AirXpanders Patient Activated CoNtrolled Tissue ExpanDer System for Breast Reconstruction) trial. XPAND is a prospective, randomized, controlled, open-label pivotal study of the company’s AeroForm™ breast tissue expansion device in mastectomy patients undergoing breast reconstruction.
The first patient that received the AeroForm device was implanted in New York City on November 30th. An additional 3 patients have been enrolled in the trial and are awaiting treatment.
“Given the data collected in the recently-published PACE feasibility trial, the AeroForm device has the potential to offer breast cancer patients a needle free and more convenient tissue expansion process as part of breast reconstruction following a mastectomy,” said Leroy Young, M.D., FACS, Mercy St. Louis Cancer and Breast Institute, Principal Investigator of the XPAND trial. “This study will compare the patient-controlled, carbon-dioxide-based AeroForm device to the standard saline injection method, an often arduous process that has historically been a major deciding factor against breast reconstruction for many women.”
The tissue expansion process is often required after mastectomy to stretch the skin and the muscle of the chest wall so a permanent breast implant can be inserted. Traditionally, surgeons implant a saline tissue expander under the skin and pectoral muscle at the site of the mastectomy. During subsequent weekly office visits, 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.
AirXpanders designed the AeroForm tissue expander system 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 eliminates the need for invasive saline injections by using compressed carbon dioxide that is gradually released through a small internal valve to fill the expander. Following a standard implant procedure, the patient can use the remote control at home to perform the expansion process as directed by the surgeon.
“This is a momentous occasion for the company, as we begin collecting the data that will be submitted to the FDA in support of our 510(k) application,” said Scott Dodson, AirXpanders President and Chief Executive Officer. “Each year 250,000 women undergo a mastectomy, and for those women who choose reconstruction, we believe that the AeroForm will prove to be an empowering device that will allow these patients to move on with their lives, have more control during the tissue expansion process and have the potential to avoid disruptive weekly doctor’s visits.”
During the company’s feasibility trial in Australia, the average expansion time associated with the AeroForm remote-controlled tissue expander was 15 days, a fraction of the time typically required using traditional saline expanders.
The trial is designed to directly compare the outcomes of tissue expansion of the traditional saline expansion method to the investigational AeroForm, remote-controlled, needle-free tissue expander. Enrollment will continue until a total of 92 AeroForm devices and 46 saline expanders have been implanted in patients.
U.S. Food and Drug Administration (FDA) has granted the company an Investigational Device Exemption (IDE) to conduct the clinical trial.Participating sites include hospitals in Boston, New York, St. Louis, San Diego, Sacramento, San Jose and Durham, NC.
For more information on the study, please visit http://clinicaltrials.gov/ct2/show/NCT01425268.
About AirXpanders AirXpanders Inc. 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 recovering one’s feminine shape after mastectomy 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 the current standard-of-care. 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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