5th Prospective Trial Confirms Physician and Patient Satisfaction, Ease of Use and Convenience with AeroForm® Tissue Expander System

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Data on delivery of radiation with AeroForm in vivo with no increased toxicity also presented

[junkie-alert style=”grey”] New data on the use of AeroForm® Tissue Expander System was presented during the 86th Plastic Surgery: The Meeting, the annual scientific meeting of the American Society of Plastic Surgery (ASPS), October 6-10, in Orlando, FL. [/junkie-alert]

Dr. Jeffrey Ascherman of Columbia University presented new data from the XPAND II continued access trial. The study presented the results of 50 women who received AeroForm. The primary endpoint was met with 100% of patients achieving successful expansion and exchange to breast implant (precluding non-device related failures). With AeroForm, women achieved tissue expansion in a median time of 21 days, and completed the reconstruction process in a median time of 115 days. Both surgeons and patients reported high satisfaction rates (96%). Ease of use was reported as 98% for patients and 94% for physicians, and convenience was rated at 100% for patients and 94% for physicians.

On the trial, Scott Dodson, President & CEO, AirXpanders said, “XPAND II, our fifth prospective trial, reaffirms the consistent, outstanding performance and patient benefits of the AeroForm System we’ve seen across all of our clinical trials and in commercial use.”  He added, “With our full U.S. launch underway, we are pleased to be able to provide plastic surgeons access to the most studied, peer reviewed and published tissue expander on the market today.”

In addition, Dr. Martin Keisch, a radiation oncologist from Miami Shores, FL, presented on treating patients with radiation therapy with AeroForm in vivo. He presented data from the experience of Genesis Cancer Care in Perth, Australia, where more than 10 AeroForm patients have undergone radiation. The analysis showed that by considering specific radiation planning techniques related to the components of the expander, the radiation oncology team could safely deliver radiotherapy with an AeroForm expander in place. Additionally, no increase in acute toxicity was seen.

AeroForm offers a needle-free alternative for women who choose reconstructive surgery following a mastectomy. AeroForm is activated by a handheld wireless controller that administers small amounts of carbon dioxide (CO2) up to three times a day, to gradually stretch the tissue to prepare for a breast implant. With the push of a button from the wireless controller, a preprogrammed amount of CO2 is delivered in seconds, allowing the patient to continue with her daily activities while preparing for reconstruction.