CE Mark For Thoracic-Length Heli-FX Aortic Aneurysm Graft System

In short

Californian endovascular specialist company Aptus Endosystems, Inc. has received CE clearance for its thoracic-length Heli-FX™ system. Similar to the original Heli-FX system that was cleared for European distribution in May 2011 and designed for treating abdominal aortic aneurysms (AAA), the new system gained FDA clearance last September as we reported here. It consists of a longer delivery device with additional tip configurations to bring the innovative helical EndoAnchor™ technology to the treatment of thoracic aortic aneurysms (TAA).

Background

Each year in Europe, it is estimated that 5,000 new people are diagnosed with TAA and approximately 12,000 people are treated for TAA. In thoracic endovascular aneurysm repair (TEVAR), an alternative to open surgical repair of TAA, a minimally invasive catheter-based system is used to implant a metal and fabric endograft to isolate blood flow away from the aneurysm to prevent potential rupture and death. Complications can arise from TEVAR if the implanted endograft migrates or does not result in a seal with the vessel wall, a so-called endoleak, to effectively isolate the aneurysm.

The thoracic-length Heli-FX system allows physicians to deliver Aptus’ novel EndoAnchor technology to the thoracic aortic anatomy. The implantable EndoAnchor enables independent endograft fixation which is designed to replicate the sealing and fixation of hand suturing. The durability of hand suturing performed during open surgery is preferred but the procedure is associated with high rates of complications and mortality. Like the abdominal version, the thoracic system can be used during de novo (initial) TEVAR procedures to enhance an endograft’s inherent fixation and sealing mechanisms. In addition, the EndoAnchors can be used to repair endovascular grafts that have migrated away from the implant site and have developed endoleaks or are at risk of developing these complications. In such cases, augmented fixation and/or sealing is required to regain or maintain effective aneurysm exclusion.

Clearance of the thoracic-length Heli-FX system in Europe allows the device to be used with Cook Medical’s Zenith® TX2®, Jotec’s E-Vita®, W.L. Gore’s TAG®, and Medtronic’s Talent® Thoracic and Valiant® endografts in both initial implant and secondary repair settings. Use with other endografts has not been evaluated to date.

Physician comments

“Patients undergoing repair of their TAA still face many risks and potentially serious complications,” said Eric Verhoeven, M.D., Ph.D., Chief of Vascular and Endovascular Surgery at Klinikum Nürnberg Süd in Nuremberg, Germany. “With the new Heli-FX system for TAA, we will have the ability to reduce those risks by addressing imperfect apposition of an endograft in angulated thoracic aortic anatomies and secure grafts in anatomies where endograft migration could become an issue.”

Company comments

“The CE clearance of the Heli-FX system designed for TAA is a major milestone for the Aptus team and our European physician partners,” said James Reinstein, CEO of Aptus Endosystems. “Acceptance of the Heli-FX abdominal technology has grown significantly for use in EVAR procedures and we expect the utilization in TEVAR procedures will be more highly penetrated given the obvious benefits to patients with TAA.”

Source: Aptus Endosystems, Inc., Business Wire