Early results show safety, technical success of Heli-FX in endovascular aneurysm repair

Initial results from the ANCHOR registry show positive safety and technical success of the Heli-FX EndoAnchor System in endovascular aneurysm repair.

At VIVA 2013, James Joye, DO, interventional cardiologist at El Camino Hospital, Mountain View, Calif., presented data on the first 257 patients in the postmarket registry, which was initiated to evaluate real-world use of the Heli-FX EndoAnchor System (Aptus Endosystems).

The mechanical fastening device is designed to improve long-term durability and reduce repeat procedures in endovascular aneurysm repair, according to a company press release. It is indicated for use in patients whose grafts have had endoleak or migration, or who are at risk for either at implantation, Joye said.

The global, prospective, multicenter registry is scheduled to last for 5 years. It has two arms, one for patients with grafts at risk for endoleak or migration (primary arm; n=1,000) and one for patients with grafts already experiencing endoleak or migration (revision arm; n=1,000).

So far, success rates for implantation are 99.5% for the primary arm (193 of 194 patients) and 91% for the revision arm (57 of 63 patients), Joye said.

The rate of aneurysm-related reinterventions is 1.9% for all patients (primary arm, 1%; revision arm, 4.7%), he said.

Seventy-one serious adverse events (primary arm, 51; revision arm, 20) have occurred, but only 17 were related to the procedure (primary arm, 12; revision arm, five) and just one (revision arm) was related to the device, according to Joye.

“There were no unanticipated adverse device events,” he said.

The primary efficacy endpoint is successful implantation of the minimum number of fastening devices, freedom from migration at 1 year and freedom from type 1A endoleak at 1 year. The primary safety endpoint is freedom from device-related and procedure-related serious adverse events at 1 year. Secondary endpoints include all-cause mortality, treatment of abdominal aortic aneurysm or related complications after implantation and any aneurysm-related event at 30 days, he said.

“These initial ANCHOR results show the potential for a definitive solution to a long-standing limitation in [endovascular aneurysm repair]. Further study and long-term data will determine if Heli-FX is able to reduce aneurysm-related adverse events, reduce the need for secondary interventions and will assess the need for long-term follow-up,” Joye said in the release.

For more information:

Joye J. Late-breaking clinical trials. Presented at: VIVA Conference 2013; Oct. 8-11, 2013; Las Vegas.

Disclosure: Joye reports financial ties to Abbott Vascular, Aptus Endosystems, BioCardia, Cardiokinetix, Cook Medical, Covidien, ev3, Flexible Stenting Solutions, Gore, Manhole Inc., Medtronic and PQ Bypass.