Aptus' Thoracic-Length Heli-FX Aortic Securement System Receives CE Mark Approval

April 2, 2013—Aptus Endosystems, Inc. (Sunnyvale, CA) announced that it has received CE Mark approval for its thoracic-length Heli-FX system, which is similar to the original Heli-FX system that was cleared for European distribution in May 2011 for the treatment of abdominal aortic aneurysms (AAA). The new system consists of a longer delivery device with additional tip configurations to allow the company's helical EndoAnchor technology to be used for the treatment of thoracic aortic aneurysms (TAA).

According to Aptus' press release, the implantable EndoAnchor enables independent endograft fixation that is designed to replicate the sealing and fixation of hand suturing. The company noted that the durability of hand suturing performed during open surgery is preferred, but the procedure is associated with high rates of complications and mortality. Like the abdominal version, the thoracic system can be used during de novo thoracic endovascular aneurysm repair 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, stated the company.

“Patients undergoing repair of their TAA still face many risks and potentially serious complications,” commented Eric Verhoeven, MD, in the company's press release. Dr. Verhoeven, who serves as Chief of Vascular and Endovascular Surgery at Klinikum Nürnberg Süd in Nuremberg, Germany, added, “With the new Heli-FX system for TAA, we will have the ability to reduce those risks by addressing imperfect apposition of an endograft in angulated thoracic aortic anatomies and secure grafts in anatomies where endograft migration could become an issue.”

Aptus advised that clearance of the thoracic-length Heli-FX system in Europe allows the device to be used with the Zenith TX2 (Cook Medical, Bloomington, IN), the E-Vita (Jotec GmbH, Hechingen, Germany), the TAG (Gore & Associates, Flagstaff, AZ), and the 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.