Aptus Endosystems lands FDA nod for abdominal aneurysm device
Aptus Endosystems lands 510(k) clearance from the FDA for its thoracic-length HeliFX aortic anchor for repairing abdominal aortic aneurysms.
Aptus Endosystems lands FDA nod for abdominal aneurysm device [1]
Aptus Endosystems said it won 510(k) clearance from the FDA for its thoracic-length HeliFX aortic anchor for repairing abdominal aortic aneurysms. The first iteration of the device earned FDA clearance [2] – and its share of controversy [3] – in November 2011. The latest clearance came via the watchdog agency's de novo device review protocol [4]. Aptus counts former Boston Scientific [5] (NYSE:BSX [6]) CEO James Tobin as a member of its board of directors [7].