FDA approves aortic securement system for TAAs
The FDA has granted 510(k) clearance for the thoracic-length HeliFX aortic securement system, an updated system to the one cleared in November 2011 to treat abdominal aortic aneurysms. The new system from Aptus Endosystems has a longer delivery device with additional tip configurations to bring the helical EndoAnchor technology to the treatment of thoracic aortic aneurysms (TAA).
The implantable EndoAnchor enables endograft fixation, and is designed to replicate the sealing and fixation of hand suturing performed during open surgical repair of aortic aneurysms, Sunnyvale, Calif.-based Aptus said in a press release. It can be used during de novo thoracic endovascular aortic repair procedures. In addition, the EndoAnchors can be used to repair endovascular grafts that have migrated away from the implant site and have developed endoleaks.
Clearance of this 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, according to the company. Use with other endografts has not been evaluated to date.
The implantable EndoAnchor enables endograft fixation, and is designed to replicate the sealing and fixation of hand suturing performed during open surgical repair of aortic aneurysms, Sunnyvale, Calif.-based Aptus said in a press release. It can be used during de novo thoracic endovascular aortic repair procedures. In addition, the EndoAnchors can be used to repair endovascular grafts that have migrated away from the implant site and have developed endoleaks.
Clearance of this 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, according to the company. Use with other endografts has not been evaluated to date.