Endostaples Have Arrived: Will They Become Important Tools in the Hands of Aortic Interventionists?
- Wed, 12/14/11 - 11:10am
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Last month, Aptus Endosystems, Inc. announced that it received 510(k) clearance from the U.S. Food and Drug Administration for the company’s endostapling system, which will now be known as the HeliFX aortic securement system, for use during endovascular aneurysm repair (EVAR). According to the company, the device’s helical anchor technology enables independent endograft fixation and is designed to “duplicate” surgical sutures performed during operative repair of abdominal aortic aneurysms. The HeliFX system is intended for the repair of endovascular grafts that migrated from the implant site, developed endoleaks, or are at risk of developing these complications. The device presumably provides the required enhanced fixation and/or sealing to regain or maintain effective aneurysm exclusion. The system also can be used during de novo EVAR procedures.
Regulatory approval in the United States allows HeliFX to be used with the Zenith (Cook Medical) and Excluder endografts (Gore & Associates), as well as the AneuRx, Endurant, and Talent endografts (Medtronic, Inc.) in both initial implant and secondary repair settings. Use with other endografts has not yet been evaluated. It remains to be seen how often and in which situations these devices will be used. Cost-wise, use of a set of endostaples will probably be equivalent to implanting an additional endograft iliac limb (or a little more).
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