FDA Clears Aptus's 28-mm Tip Reach Heli-FX Guide for Wide-Neck AAA Treatment

May 28, 2013—Aptus Endosystems, Inc. (Sunnyvale, CA) announced that it received 510(k) clearance from the US Food and Drug Administration (FDA) for its 28-mm tip reach Heli-FX guide, which is a line extension of the company's original Heli-FX system, to enhance endovascular treatment of wide-neck abdominal aortic aneurysms.

The company noted that it will introduce the new 28-mm Heli-FX abdominal aortic aneurysm guide as well as the recently approved Heli-FX thoracic system at the Society of Vascular Surgery's 2013 Vascular Annual Meeting being held May 30–June 1 in San Francisco, California.

According to Aptus, the Heli-FX system can be used during primary endovascular aneurysm repair (EVAR) procedures to enhance an endograft's inherent fixation and sealing mechanisms, potentially improving the long-term durability of the aneurysm repair. The system can also repair endovascular grafts that have developed endoleaks or migrated away from the implant site, or are at risk of developing these common complications after EVAR. The company noted that in such cases, augmented fixation and/or sealing is required to regain or maintain effective aneurysm exclusion. The 28-mm Heli-FX guide is a line extension of the original 22-mm Heli-FX guide and facilitates the precise positioning and implantation of the helical EndoAnchors in aortic necks up to 32 mm in diameter.

“The longer-reach, 28-mm guide gives physicians a greater ability to implant anchors and improve the long-term durability of EVAR,” commented William P. Jordan, MD, in Aptus' press release. Dr. Jordan is Chief of the Section of Vascular Surgery at the University of Alabama Hospital in Birmingham, Alabama. He continued, “This will be a useful addition to the Heli-FX system, especially when treating difficult aortic anatomy.”