Longer reach guide catheter nets 510(k) status

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The FDA has given 510(k) clearance to Aptus Endosystems for its 28mm Tip Reach Heli-FX Guide, a longer reach guide catheter used in the treatment of wide neck abdominal aortic aneurysms.

The Heli-FX system can be used during primary endovascular aneurysm repair procedures to enhance an endograft’s inherent fixation and sealing mechanisms and potentially improve the long-term durability of the aneurysm repair. The system also can repair endovascular grafts that have developed endoleaks, migrated away from the implant site or are at risk of developing these complications.

The 28mm Heli-FX Guide is a line extension of the original 22mm Heli-FX Guide and facilitates the positioning and implantation of the helical EndoAnchors in aortic necks up to 32mm in diameter, according to Sunnyvale, Calif.-based Aptus.