Endologix, Inc. has got  U.S. Food and Drug Administration (FDA) approval of the PMA supplement for its Powerlink XL® System, which includes new suprarenal stent grafts as well as the new Powerlink XL stent graft.

This approval substantially broadens the Company’s treatment indications for the Powerlink System, which is used in the minimally invasive treatment of abdominal aortic aneurysms (AAA). The Powerlink XL System was evaluated in an IDE clinical study and approved for the treatment of AAA patients with proximal aortic necks between 23 millimeters and 32 millimeters.

“This approval is important for patients with AAA, because the Powerlink XL System offers the lowest profile catheter of all commercially available devices in the U.S. indicated for aortic necks greater than 26 millimeters,” said John McDermott, Endologix President and CEO. The low profile Powerlink XL System expands the market for AAA procedures by enabling treatment in patients with limited or difficult vascular access.

In addition to its low profile, the Powerlink and Powerlink XL Systems are the only commercially available AAA devices with proximal extensions offered in both infrarenal and suprarenal configurations. By providing both design options, Endologix enables physicians to choose the most optimal device to treat a wide range of patient anatomies. Furthermore, the Powerlink XL opens a new market segment to Endologix, as approximately 15% of endovascular AAA procedures are performed in patients with aortic necks greater than 26 millimeters.