AirXpanders Inc., a company developing novel breast reconstruction technology following a mastectomy, has reported that acceptable levels of radiation therapy can be delivered through its AeroForm technology to target tissue.
In a study titled “Dosimetric impact of the AeroForm tissue expander in postmastectomy radiation therapy: An ex vivo analysis”, and published in the Practical Radiation Oncology journal, the research team evaluated the effect of the AeroForm tissue expander on the dose distribution from a simulated postmastectomy radiation treatment for breast cancer.
Women diagnosed with breast cancer who have to undergo mastectomy and want to have breast cancer reconstructive surgery can face a lengthy and painful process with the commonly used, needle-based, saline tissue expanders.
The AeroForm is a patient controlled breast tissue expander that comes equipped with a small handheld wireless controller that administers small amounts of CO2 into the device, stretching the skin to accommodate a permanent breast implant. This method eliminates the need for percutaneous saline injections, shortens tissue expansion time from months to weeks, reduces pain and discomfort experienced by patients, can improve cosmetic outcomes for a natural form and shape and reduces overall time and costs
“By testing radiation delivery levels on a phantom model, we were able to confirm that it’s possible for breast cancer patients to receive adequate doses of radiation therapy while undergoing patient-controlled tissue expansion as part of the breast reconstruction process. These are important findings because many women start to undergo the first stages of breast reconstruction during their mastectomy surgery and radiation is often required afterwards to ensure that all of the cancer has been destroyed. Based on data from clinical trials published to date, the patient-controlled expander represents a significant improvement over standard saline expansion in terms of patient satisfaction, pain levels and expansion time, so we’re pleased to see that it could be possible for women undergoing breast reconstruction to have this as an option during various stages of their cancer treatment.” Janaki Moni, M.D., lead author of the study, said in an AirXpanders press release.
The results from the study revealed that clinically acceptable amounts of radiation were delivered despite the presence of carbon-dioxide and a metallic reservoir.
“This new study adds to the growing body of clinical data showing that the AeroForm is a viable tissue expansion option for women at various stages of their cancer therapy,” Scott Dodson, AirXpanders President and Chief Executive Officer, added in the press release. “We are actively working to enroll the final patients into our U.S. pivotal study known as XPAND and remain on track to close the study very soon, while we simultaneously roll out AeroForm to key plastic surgeons in the Australian market.”