Aptus EndoStapling System Receives CE Mark Approval

May 23, 2011—Aptus Endosystems, Inc. (Sunnyvale, CA) announced CE Mark approval for their EndoStapling system. The device's helical staple technology enables independent endograft fixation and is designed to mimic the hand suturing performed during open surgical repair of abdominal aortic aneurysms.

According to the company, the EndoStapling system allows interventionists to fix endovascular aneurysm repair (EVAR) grafts that have exhibited or are at risk of migration or endoleaks and in which augmented radial fixation and/or sealing is required to regain or maintain effective aortic aneurysm exclusion. The system can also be used during de novo EVAR procedures to enhance an endograft's inherent fixation and sealing mechanisms.

In addition to its use with the Aptus endografts, which received CE Mark approval in 2009, the company's EndoStapling system has received CE Mark approval for use with the Zenith (Cook Medical, Bloomington, IN), Excluder (Gore & Associates, Flagstaff, AZ), AneuRx, Endurant, and Talent endografts (Medtronic, Inc., Minneapolis, MN) in both initial implant and secondary repair settings. Use with other endografts has not been evaluated, the company advised.

“The use of the Aptus EndoStapling system will be a great advantage to simplify revision surgery for migrated endografts,” commented Jean Paul de Vries, MD. “The ability to staple migrated endografts to the aortic wall and to fixate extension cuffs will overcome most migrations and type IA endoleaks. This system truly mimics a sutured anastomosis.” Dr. de Vries added, “EndoStapling can improve fixation of de novo endografts in challenging proximal necks—short, large, and angulated—and can potentially reduce distal migration during follow-up.”

Theodossios Perdikides, MD, stated, “We found the system to be a highly sophisticated, user-friendly device designed to be applied easily by the average user, requiring a short learning curve. I believe this innovative technology promises to prevent or repair major EVAR-related pitfalls that can lead to failure or even disaster.”

“This is a big leap forward concerning minimally invasive bailout for endografts at risk for migration,” said Joerg Tessarek, MD. “Not only for traditional infrarenal devices, but also for complex fenestrated or branched grafts where migration affects target vessel patency, this will be a helpful tool to provide graft stability.”