Aptus Endosystems has obtained the US Food and Drug Administration's (FDA) 510(k) approval for its new thoracic-length HeliFX aortic securement system, designed for treating thoracic aortic aneurysms (TAA).
The HeliFX system’s delivery device with additional tip configurations enables physicians to deliver the company’s EndoAnchor technology to enable endograft fixation in the thoracic aortic anatomy.
In addition, the HeliFX system can be used to repair endovascular grafts that have migrated away from the implant site and have developed endoleaks during performing thoracic endovascular aneurysm repair (TEVAR) procedures.
Stanford University School of Medicine cardiothoracic surgery professor 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 surgery vascular chief and surgery associate professor David Deaton said the, "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."
The company said with the clearance of the new HeliFX system in the US, the device can now be used in 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.