Aptus Endosystems announced on 2 April 2013 that it 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, the new system consists of a longer delivery device with additional tip configurations to bring the innovative helical EndoAnchor technology to the treatment of thoracic aortic aneurysms.
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. Like the abdominal version, the thoracic system can be used during de novo 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.
“Patients undergoing repair of their thoracic aortic aneurysms still face many risks and potentially serious complications,” said Eric Verhoeven, chief of Vascular and Endovascular Surgery at Klinikum Nürnberg Süd in Nuremberg, Germany. “With the new Heli-FX system for thoracic aortic aneurysms, 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.”
“The CE clearance of the Heli-FX system designed for thoracic aortic aneurysms 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 thoracic aortic aneurysms.”
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.