Aptus Endosystems has received CE mark approval from the European Union for its thoracic-length Heli-FX system for thoracic aortic aneurysms (TAA) treatment.
Featuring a longer delivery device with additional tip configurations, the device 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 catheter-based device also allows physicians to deliver Aptus' EndoAnchor technology that enables independent endograft fixation and enhances an endograft's inherent fixation and sealing mechanisms, according to the company.
EndoAnchor can also 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, "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."
Aptus said with the European approval, the product can now 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.
