Aptus' HeliFX Securement System Cleared for TEVAR

September 13, 2012—Aptus Endosystems, Inc. (Sunnyvale, CA) announced 510(k) clearance from the US Food and Drug Administration for its thoracic-length HeliFX aortic securement system for the treatment of thoracic aortic aneurysms (TAAs).

According to the company's press release, the thoracic HeliFX with helical EndoAnchor technology is similar to the original HeliFX system that was cleared in November 2011 for endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms. The new HeliFX device is designed to treat TAAs with a longer delivery device and additional tip configurations. 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.

Aptus stated that the device can be used during de novo thoracic endovascular aneurysm repair (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, noted the company.

“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,” commented Michael Dake, MD, in the company's announcement. Dr. Dake is Professor of Cardiothoracic Surgery at Stanford University School of Medicine. “The HeliFX system offers physicians a new endovascular capability to improve fixation and sealing of TEVAR endografts and potentially improve procedural durability for patients.”

David Deaton, MD, Associate Professor of Surgery and Chief of Vascular and Endovascular Surgery at Georgetown University Hospital, added, “The demonstrated capabilities of HeliFX for infrarenal EVAR in duplicating the strength of a hand-sutured aortic anastomosis will be even more valuable 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.”

Aptus advised that clearance of the new HeliFX System in the United States allows the device to be used with the Zenith TX2 (Cook Medical, Bloomington, IN), TAG (Gore & Associates, Flagstaff, AZ), and Talent thoracic and Valiant endografts (Medtronic, Inc., Minneapolis, MN) in both initial implant and secondary repair settings. Use with other endografts has not been evaluated to date.