FDA nod to Endologix’s IntuiTrak™ Delivery System

The U.S. Food and Drug Administration has approved Endologix, Inc.’s IntuiTrak™ Delivery System. The novel system will facilitate minimally invasive delivery. It will help  deploy the Powerlink stent graft [indicated for endovascular repair of AAA abdominal aortic aneurysms (AAA)]. The device has improved flexibility. It features advanced hemostasis control. An integrated sheath introduces ancillary devices during AAA procedure, reducing blood loss and the procedure time.

FDA approves PMA supplement for Endologix’s Powerlink XL® System

The U.S. Food and Drug Administration has approved PMA supplement for Endologix, Inc.’s Powerlink XL® System that includes novel suprarenal stent grafts along with the Powerlink XL stent graft. The system used in the minimally invasive procedures to treat abdominal aortic aneurysms (AAA), now, has broadened indication. Endologix provides a choice to physicians for the optimal device for the treatment of various patient anatomies. This marks the entry of Endologix in a new market segment as 15% of endovascular AAA applications are for patients having aortic necks greater than 26 millimeters.