ANCHOR Postmarket Registry Data Presented for Aptus's Heli-FX EndoAnchor EVAR System

October 8, 2013—Aptus Endosystems, Inc. (Sunnyvale, CA) announced initial results from its ANCHOR postmarket registry evaluating the use of the company's Heli-FX EndoAnchor system in endovascular aneurysm repair (EVAR). James Joye, DO, interventional cardiologist at El Camino Hospital, presented the data at the VIVA 2013: Vascular Interventional Advances conference held on October 8–11 in Las Vegas, Nevada.

ANCHOR is a global, multicenter, prospective, postmarket registry evaluating the Heli-FX aortic securement system in EVAR and capturing data on the use of the technology as well as acute and long-term procedural outcomes.

According to the company, these early results from the first 250 patients demonstrate the safety and acute technical success of utilizing Heli-FX in primary and revision EVAR procedures. Heli-FX is a mechanical fastening device that connects the endograft to the aorta and is designed to enhance the long-term durability of the procedure and reduce the risk of repeat interventions in EVAR.

Initial results from the registry showed acute safety and efficacy results with Heli-FX. These results also showed that Heli-FX is used in conjunction with a variety of endografts and in both primary and revision EVAR procedures, with primary prophylactic use outweighing revision cases by approximately three to one. In revision procedures, Heli-FX was used to repair type I endoleaks or endograft migration in patients with previously placed endografts, with 91% acute technical success.

Aptus Endosystems stated that the Heli-FX EndoAnchor system is a mechanical fastening device that is designed to enhance the long-term durability and reduce the risk of repeat interventions in EVAR. The device's helical anchor technology enables independent endograft fixation and sealing and is designed to replicate hand suturing performed during open surgical repair of aneurysms. By deploying small helical screws to connect the graft to the aorta, Heli-FX seeks to provide a permanent seal and fixation, similar to the stability achieved in an open surgical anastomosis. The Heli-FX system can be used during primary EVAR procedures to enhance an endograft's inherent fixation and sealing mechanisms. It can also be used to repair endovascular grafts that have developed endoleaks, migrated away from the implant site, or are at risk of developing these complications, which are often seen after EVAR.