Medtronic has announced that its Heli-FX EndoAnchor system demonstrated consistent and durable outcomes in patients with complex aortic disease in the Anchor registry.
The Heli-FX EndoAnchor system has showed durability, safety and efficacy in patients with complex aortic abdominal aneurysm (AAA) anatomy, specifically hostile aortic neck anatomies.
It has been designed to offer fixation and sealing between endovascular aortic grafts and the native artery. It can be implanted at the time of the initial endograft placement or during a secondary procedure.
The results are based on three-year data from the primary prophylactic and therapeutic revision arms of the firm’s Anchor registry, which is a global, multi-center, multi-arm and post-market registry assessing the real-world applicability of the Heli-FX EndoAnchor system.
Medtronic aortic and peripheral vascular division’s aortic business general manager and vice president John Farquhar said: “With Heli-FX, our focus continues to be on improving the lives of patients with complex aortic disease by broadening applicability of endovascular repair to patients who have traditionally been challenging to treat.
“These data further validate the use of EndoAnchor fixation as a long-term solution that enhances outcomes and durability in patients with complex aortic anatomies.”
According to the company, the clinical evidence showed the Heli-FX EndoAnchor system offers additional security when used with approved endovascular stent grafts in patients with hostile infrarenal AAAs.
Over 800 AAA patients treated with Heli-FX in combination with primarily Medtronic, Gore, Cook, and Jotec grafts were recruited in the Anchor registry.
Most of the patients in the registry secured EndoAnchor implants prophylactically, and the smaller group received them following a previously failed endovascular repair (EVAR) treatment.
Specific results through three years comprised of low rates of type Ia endoleaks, high rates of freedom from secondary procedures to treat Type Ia endoleak based on Kaplan-Meier estimate and high rates of freedom from aneurysm related mortality (ARM) based on Kaplan-Meier estimate.
Anchor registry co-principal investigator Dr William Jordan said: “Hostile aortic necks are frequently seen in clinical practice and have historically presented challenges for physicians treating patients through an endovascular approach.”