AirXpanders pivotal IDE trial meets endpoint

AirXpanders said the pivotal investigational device exemption trial of its AeroForm tissue expander met its primary endpoint. Results from the trial were presented at the American Society of Plastic Surgeon’s meeting in Boston. 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 Palo Alto, Calif.-based company said. “The excellent results from the Xpand pivotal trial validate that the AeroForm expander is a safe and effective alternative treatment option for the many women undergoing mastectomy and breast reconstruction. We believe women will be pleased to have the choice to control their expansion in a more convenient and faster way, during their difficult road to breast reconstruction. We have already submitted the pivotal study results to the FDA under the 510(k) clearance process so as to make this device available to all women who are considering breast reconstruction following their mastectomy,” AirXpanders CEO Scott Dodson said in prepared remarks. The 150-patient trial examined women ages 18 to 70 reeiving breast tissue expansion, either with the company’s device or standard saline tissue expanders. The endpoint for the trial was defined as “successful expansion and exchange to a permanent implant,” which the company said it met. The patients treated with the AeroForm had shorter expansion and recons...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Cosmetic/Aesthetic Women's Health AirXpanders Source Type: news