12 08 11 | Medical Device Daily article by Amanda Pedersen

First Patient Treated in IDE Trial of AeroForm Device

AirXpanders (Palo Alto, California) reported that the first patient has been treated in the AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction XPAND 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 on November 30. An additional three patients have been enrolled in the trial and are awaiting treatment.

FDA granted the company an IDE to conduct the trial a few months back (Medical Device Daily, September 1, 2011). Participating sites include hospitals in Boston, New York, St. Louis, San Diego, Sacramento, San Jose, and Durham, North Carolina.

“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, MD, 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.

Young told Medical Device Daily that another advantage to the AeroForm procedure, from a surgeon’s perspective, is being able to remove those subsequent office visits related to the procedure, which the surgeon does not get reimbursed for. He also noted that if the patient undergoes a standard saline expansion procedure later in the year and the follow-up visits roll into the new year, that patient has to meet their insurance deductible again.

Although infection is rare with the traditional saline expansion method, Young noted that the new proceduredoes reduce the risk of infection from repeated needle injections.

The AeroForm method should offer several patient benefits as well, he added. “Not every patient complains of pain from having the saline injection, but some do [experience discomfort],” Young said. “Like any shot, no one looks forward to getting stuck with a needle.”

The new procedure also is considerably quicker than the standard saline expansion method, Young said. “This allows you to complete reconstruction quicker and I believe...it is more comfortable for the patient and it’ll be more convenient.”

The only added inconvenience associated with the AeroForm method that Young noted was that the patient is not allowed to fly while they have the device implanted.
“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, president/CEO of AirXpanders. “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.

AirXpanders is backed by GBS Venture Partners, Prolog Ventures, Heron Capital, and Shalon Ventures. The company has previously raised $8 million through a $5 million Series C financing led by GBS Ventures in April 2010 and an additional $3 million working capital line from Oxford Finance in February.

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