Marin General Hospital Enrolls Patients in Study of New Tissue Expander

First AeroForm™ Implant in Marin County

GREENBRAE, CA — Marin General Hospital is enrolling mastectomy patients into a clinical study designed to evaluate a new tissue expansion method for those who choose to undergo mastectomy and breast reconstruction. The clinical study directly compares the outcomes of the traditional saline tissue expansion method to a new, needle-free, tissue expansion system that eliminates the need for injections and allows the patient to control the procedure at home or in the office.

Tissue expansion is a process required to stretch the skin and tissue at the site of a mastectomy so that a standard saline or silicone breast implant can be placed.

“Traditionally, women undergoing breast reconstruction have had to endure a long process of inconvenient and often painful weekly inflations using conventional saline expanders to create a pocket for a standard implant following a mastectomy,” says Khashayar Mohebali, MD, a Corte Madera-based plastic surgeon who performs breast reconstruction surgery at Marin General Hospital. “This investigational system eliminates the need for injections by allowing the patient to dose small amounts of compressed carbon-dioxide into the expander using a remote control. It’s a needle-free process for the patient to deliver gradual daily doses of compressed carbon-dioxide into the expander.”

Patients in the study will be randomly selected to receive the investigational expander, known as The AeroForm™ Patient Controlled Tissue Expander System or a traditional saline expander. The patients who receive the AeroForm™ will use a wireless remote control to trigger the release of small, regulated amounts of carbon-dioxide to fill the tissue expander. Once the patient’s tissue is adequately expanded, she will return to have the expander removed and a permanent implant placed.

The current standard of care in tissue expansion involves implanting a saline expander under the skin and pectoral muscle following a mastectomy procedure. The patient returns to her doctor weekly for bolus saline injections, which many patients say is the most painful, difficult part of the reconstruction process, Dr. Mohebali explained.

Marin General Hospital and other hospitals across the U.S. are participating in the study. Enrollment will continue until a total of 92 AeroForm™ expanders and 46 saline expanders have been implanted in patients. AeroForm™ will be evaluated based on its ability to successfully and safely expand the tissue to the point that the expander can be replaced with a standard breast implant. Secondary measurements will include the average number of days needed to achieve the desired expansion, total reconstruction time, pain and patient satisfaction.

The AeroForm™ Patient Controlled Tissue Expander was designed and manufactured by AirXpanders, a medical device company in Palo Alto, CA. The U.S. Food and Drug Administration (FDA) has granted AirXpanders an Investigational Device Exemption (IDE) to conduct the study and it has been approved for enrollment.

For more information on the study, please visit clinicaltrials.gov (NCT01425268).

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