AirXpanders, a California-based breast reconstruction company, recently received EU CE Mark approval for its non-needle, self-operated tissue expansion system. The AeroForm device is used to stretch muscles and skin to create room for a breast implant. Since it can be challenging for doctors to create a space for an implant without deforming breast tissue, the AeroForm device is a useful tool for many patients who are getting an implant post-mastectomy. In addition to reducing surgery times for patients, the AeroForm ensures that a breast is expanded in an even and consistent manner. This ensures that an implant will have a well-balanced and realistic fit.
In a set of prepared remarks, CEO Scott Dodson stated, "We are extremely pleased that the AeroForm has received this important regulatory milestone that will give women outside of the United States access to a patient-friendly option for tissue expansion when undergoing breast reconstruction after a mastectomy." He continued, "The company will begin the formalization of its international distribution plan over the next few months while we simultaneously complete our ongoing IDE trial in the U.S."
Most traditional tissue expansion systems use a saline solution. This saline solution is pumped into a special expander that is placed under the pectoral muscle and skin after surgery. In many cases, traditional saline tissue expansion systems take six months or more for proper expansion.