The European Union has granted CE mark certification to Aptus Endosystems' thoracic-length Heli-FX system for the treatment of thoracic aortic aneurysms (TAA).
The catheter-based device, which is based on the company's original Heli-FX system for the treatment of abdominal aortic aneurysms (AAA), features a longer delivery device with additional tip configurations.
The thoracic-length Heli-FX system implants a metal and fabric endograft to isolate blood flow away from the aneurysm to prevent potential rupture and death during thoracic endovascular aneurysm repair (TEVAR).
The system also allows physicians to deliver Aptus' novel EndoAnchor technology to the thoracic aortic anatomy.
EndoAnchor enables independent endograft fixation and enhances an endograft's inherent fixation and sealing mechanisms, according to the company.
In addition, the technology has the ability to repair endovascular grafts that have migrated away from the implant site and have developed endoleaks or are at risk of developing these complications.
Klinikum Nurnberg Süd, Germany, vascular and endovascular surgery chief Eric Verhoeven said patients undergoing repair of TAA still face many risks and potentially serious complications.
"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," Verhoeven said.
Aptus Endosystems CEO James Reinstein said; "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."
With the European approval, the thoracic-length Heli-FX system can be used along with Medtronic's Talent Thoracic and Valiant endografts in both initial implant and secondary repair settings, Cook Medical's Zenith TX2, Jotec's E-Vita as well as WL Gore's TAG.