Aptus Endosystems has received FDA clearance for its thoracic-length HeliFX Aortic Securement System. The thoracic length HeliFX uses the same helical endoanchors as the original HeliFX system that is purposed for abdominal aneurysms. However, the delivery device is longer in order to reach the thoracic aorta and comes with additional tip configurations.
The system can be used to improve fixation and sealing of TEVAR (thoracic endovascular aneurysm repair) endografts, either in primary cases or to fix endoleaks and stent migration.
The new HeliFX System allows physicians to deliver Aptus’ novel EndoAnchor technology to the thoracic aortic anatomy. The implantable EndoAnchor enables independent endograft fixation, and is designed to replicate the sealing and fixation of hand suturing performed during open surgical repair of aortic aneurysms. It 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 new HeliFX System in the U.S. allows the device to be used with Cook Medical’s Zenith® TX2®, 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.
Product page: HeliFX Aortic Securement System…