AirXpanders said today it will submit an application for de novo classification with the FDA for its AeroForm tissue expander.
The shift comes based upon advice the Palo Alto, Calif.-based company received from the FDA regarding its 510(k) submission, AirXpanders said.
The AeroForm tissue expander is designed for use in post-mastectomy breast reconstructions to expand and stretch the skin and underlying muscle prior to a permanent breast implant, the company said.
“The de novo process is used when there is no identical predicate device in the same medical field upon which to make comparisons. With the clearance of the AeroForm System through the de novo process as a low to moderate risk device, AeroForm would become its own predicate for future submissions,” CEO Scott Dodson said in a press release.
AirXpanders said it would continue dialogue with the FDA, with a formal review of the de novo application slated for the 2nd quarter of 2016. The de novo application process has a 120-day review cycle, the company said.
The shift is the result of the company’s FDA-approved 150-patient Xpand pivotal trial which met its primary safety and efficacy endpoints last month, AirXpanders said.
The trial, along with 3 Australian prospective trials will serve as the basis for the FDA clearance.
