The US Food and Drug Administration (FDA) has granted 510(k) clearance to Aptus Endosystems’ thoracic-length HeliFX aortic securement system, designed for treating thoracic aortic aneurysms (TAA).
The device, which comes with additional tip configurations, allows physicians to deliver the company’s EndoAnchor technology to enable endograft fixation in the thoracic aortic anatomy.
In addition, the new system can be used to repair endovascular grafts that have migrated away from the implant site and have developed endoleaks during thoracic endovascular aneurysm repair (TEVAR) procedures.
Stanford University School of Medicine cardiothoracic surgery professor Dr Michael Dake said; "Complications from TEVAR such as endograft migration and endoleaks are even more critical in this patient population given the high surgical morbidity and mortality rates."
Georgetown University Hospital endovascular and vascular surgery chief and surgery associate professor David Deaton said the demonstrated capabilities of the system for infrarenal EVAR in duplicating the strength of a hand-sutured aortic anastomosis will play a crucial role in the challenging environment of the thoracic aorta.
"The TAA HeliFX will allow surgeons greater control over the fixation and positioning of TEVAR devices and has promise for significantly reducing the susceptibility of TEVAR to the devastating consequences of late failure resulting from migration or aortic dilatation," Deaton said.
With the clearance of the new system in the US, the company claims that the device can now be used in Cook Medical’s Zenith TX2, WL Gore’s TAG and Medtronic’s Talent Thoracic and Valiant endografts in both initial implant and secondary repair settings.