Good Samaritan Hospital Enrolls Patients in Study of New Tissue Expansion Method for Mastectomy Patients Undergoing Breast Reconstruction

CAMPBELL, CA--(Marketwire - Jun 11, 2012) - Good Samaritan Hospital today announced it is enrolling patients into a clinical study designed to evaluate a new tissue expansion method for mastectomy patients who are planning to undergo breast reconstruction. The device, The AeroForm™ Patient Controlled Tissue Expander was designed and manufactured by AirXpanders, a medical device company in Palo Alto, Calif. The aim of the study is to evaluate an investigational, remote-controlled, needle-free, carbon dioxide-based system as compared to a traditional saline expander. Tissue expansion is a process required to stretch the skin and tissue at the site of a mastectomy so that a permanent breast implant can be placed.

"Traditionally, women undergoing breast reconstruction have to endure a long process of inconvenient and often painful inflations using conventional saline expanders to create a pocket for a permanent implant following a mastectomy," said Kamakshi Zeidler, MD. "This investigational, remote-controlled system eliminates the need for saline injections by using internal, compressed carbon-dioxide that is gradually released through a small internal valve to fill the expander. The patient will be able to use the remote control to inflate the expander in small pre-set amounts on a daily basis at home, eliminating the need for weekly doctor visits."

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. The traditional saline process can take as long as five to six months, Dr. Zeidler explained.

This randomized controlled clinical study is designed to directly compare the outcomes of tissue expansion of the traditional saline expansion method to the investigational, remote-controlled tissue expander. Good Samaritan Hospital and other hospitals across the U.S. are participating. Enrollment will continue until a total of 92 AeroForm™ expanders and 46 saline expanders have been implanted in patients. The device 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 permanent 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 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 by the Good Samaritan Hospital Institutional Review Board (IRB).

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

If you or someone you know is interested in joining the study, please call 408-559-7192.

About Good Samaritan Hospital
Good Samaritan Hospital is recognized regionally for acute and tertiary services, including cardiology, cardiovascular surgery, oncology, obstetrics and gynecology, Level III Neonatal Intensive Care Unit, behavioral health and specialized surgery, including minimally invasive robot-assisted surgery. Good Sam is an Advanced Primary Stroke Center, certified Chest Pain Center, county-designated STEMI receiving center and accredited Comprehensive Community Cancer Center. It consistently receives the American College of Surgeons Outstanding Achievement Award for cancer care. For more information, visit www.goodsamsanjose.com.