Palo Alto, Calif.-based breast reconstruction company AirXpanders received European CE Mark approval for its AeroForm device, a needle-free and patient-controlled tissue expansion system.
The AeroForm system uses carbon dioxide, released by the patient using a wireless remote control unit, to stretch skin and muscles to create space for a permanent breast implant.
"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," president & CEO Scott Dodson said in prepared remarks. "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."
Traditional tissue expansion requires a saline tissue expander that a surgeon places under the skin and pectoral muscle after mastectomy surgery, an expansion process which often takes up to 6 months.
The AeroForm, for which
AirXpanders in January closed a $10M Series D funding round, could achieve full expansion in as little as 14 days, according to a study published in plastic and reconstructive surgery in October, 2011.
The company plans to work with leading plastic surgeons across the European Union to generate post market clinical data on European patients, according to the press release.