It’s been the American Society of Plastic Surgeons (ASPS) annual bash this week, an event used by AirXpanders Inc., to tout favourable clinical data from the IDE study into its tissue expander device for women undergoing breast reconstruction.
Background
Recent statistics indicate that approximately only 40 percent of women complete breast reconstruction after mastectomy due to fear of a lengthy and painful process, with multiple procedures and trips to their doctor’s office. AirXpanders develops novel tissue expansion technology which is pitched at improving this situation.
The goal of reconstructive breast surgery is to recreate symmetrical natural shaped breasts after the devastating effects of mastectomy. AeroForm, a carbon-dioxide filled, remote-controlled and injection-free tissue expander is an alternative method of tissue expansion, enabling women to control the rate of expansion which can make the process easier, more comfortable and has been shown to shorten the time to expand and complete the reconstruction process. The AeroForm device is CE Marked and TGA approved for sale in Australia.
Back in August the company’s Aeroform tissue expander successfully met the primary endpoint in its IDE study, demonstrating that it can be considered a safe and effective method of expansion as an alternative to saline tissue expansion. The positive outcome of this study is a major milestone for the company and the basis on which the company is seeking FDA clearance of the device.
A total of 150 women, aged 18-70 were treated at 17 U.S. sites, randomized to the investigational or saline control groups, and underwent immediate or delayed placement of the tissue expanders. In the 98 women receiving the AeroForm expander, expansion was performed with gradual incremental dosing up to 30 cc/day. The 52 women in the saline control group received the standard course of percutaneous injections of saline. Following complete expansion, both groups went on to the final stage of reconstruction: exchange of the expander and placement of a permanent breast implant.
Treatment success in this non-inferiority trial was defined as successful expansion and exchange to permanent implant. Results showed:
- treatment success rate, excluding non-device related failures, was statistically similar between both groups
- safety profile of both devices was also similar
- time to complete the expansion and reconstruction process was statistically significantly shorter in the AeroForm group, due to the gradual, patient-controlled method of expansion (mean days to complete expansion in the AeroForm group was 21 days compared to 46 days for the saline group)
- ease of use and convenience was measured in the AeroForm group, and 98 percent of subjects found the device easy to use and convenient.
The data was presented at ASPS by Dr. Jeffrey Ascherman, chief of the division of plastic surgery at Columbia University, New York, New York and principal investigator for the XPAND pivotal trial.
Investigator comments
Dr. Ascherman stated, “The AeroForm has provided the patients in this trial with a faster and more convenient form of tissue expansion versus saline devices.
“A hidden benefit of this device is the fact that the patient can play an active role in recovering her body after breast cancer. My patients have thoroughly enjoyed this role and I am confident that this will appeal to many women across the U.S. and around the world when widely available.”
Company comments
Scott Dodson, president and CEO of AirXpanders said, “The excellent results from the XPAND pivotal trial validate that the AeroForm expander is a safe and effective alternative treatment option for the many women undergoing mastectomy and breast reconstruction.
“We believe women will be pleased to have the choice to control their expansion in a more convenient and faster way, during their difficult road to breast reconstruction. We have already submitted the pivotal study results to the FDA under the 510(k) clearance process so as to make this device available to all women who are considering breast reconstruction following their mastectomy.”
Source: PR Newswire
published: October 23, 2015 in: Clinical Studies/Trials, Congresses and Meetings, Oncology, Plastic/Reconstructive