AirXpanders wins de novo FDA clearance for AeroForm breast tissue expander

AirXpanders (ASX:AXP) said yesterday it won FDA de novo clearance for its AeroForm tissue expander system designed for breast reconstruction procedures, and announced it is preparing to launch the device in the U.S. The Palo Alto, Calif.-based company’s 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. “While approximately 70% of women who opt for reconstructive surgery undergo tissue expansion to prepare a space for breast implants, little progress has been made with regard to tissue expanders over the last 40 years. Reconstruction is one of the last phases of a long and sometimes taxing journey for women who are treated for breast cancer. They have lost time and control, and are eager to get back to their lives. Needle-free, patient-guided expansion could be a suitable option for many women undergoing the reconstruction process,” Dr. Jeffrey Ascherman of the NewYork-Presbyterian/Columbia University Medical Center said in prepared remarks. AirXpanders said it is engaging in a “range of preparatory activities” as it looks forward to a U.S. market release, including hiring sales personnel and opening dialogues with targetted hospitals for early adoption. “With the de novo FDA clearance in place, we will now accelerate the build out of our U.S. sales force with the hiring of our direct sales team, and begin initia...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cosmetic/Aesthetic Food & Drug Administration (FDA) Regulatory/Compliance Women's Health AirXpanders Source Type: news