W.L. Gore & Assoc. announced today that it won unique FDA approval for a device designed to treat tears in the innermost layers of the aortic wall, called aortic dissections.
The FDA put its seal of approval on the company’s Conformable Gore Tag thoracic endoprosthesis, giving it unique approval for treatment of aneurysm, trauma and dissection. The device is indicated to treat acute and chronic Type B dissections of the descending thoracic aorta, according to a company statement.
"Vascular surgeons have for some time awaited an approved indication for treating certain Type B aortic dissection patients since the consensus has been that endovascular stent graft repair has emerged as the treatment of choice," Massachusetts General Hospital’s Dr. Richard Cambria said in prepared remarks on behalf of the company. "Now, surgeons will be able to present patients with a minimally invasive treatment option and the exchange of information and experience among surgeons will be more acceptable now that the procedure is approved."
The Gore Tag is a minimally invasive treatment option, delivered by catheter via the femoral artery and threaded up into the chest to treat tears in the innermost layer of the aortic wall. Prior to approval of the device, patient’s only FDA-cleared alternative was management with drugs or open surgery to repair the tear, according to a press release.