Heli-FX line extension receives FDA clearance

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Aptus Endosystems announced on 28 May 2013 that it has received 510(k) clearance from the FDA for its 28mm Tip Reach Heli-FX Guide. A line extension of the original Heli-FX System, the new product enhances treatment of wide neck abdominal aortic aneurysms. The company will be launching the device as well as the recently approved Heli-FX Thoracic System at this week’s Society of Vascular Surgery (SVS) Vascular Annual Meeting in San Francisco, USA.  

The Heli-FX system can be used during primary EVAR procedures to enhance an endograft’s inherent fixation and sealing mechanisms. According to Aptus, doing so can potentially improve the long-term durability of the aneurysm repair. The system can also repair endovascular grafts that have developed endoleaks, migrated away from the implant site, 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. The 28mm Heli-FX Guide is a line extension of the original 22mm Heli-FX Guide and facilitates the precise positioning and implantation of the helical EndoAnchors in aortic necks up to 32mm in diameter. 

“The longer reach 28mm guide gives physicians a greater ability to implant anchors and improve the long term durability of EVAR. This will be a useful addition to the Heli-FX system especially when treating difficult aortic anatomy,” said William P Jordan, chief, Section of Vascular Surgery at the University of Alabama Hospital, Birmingham, USA.

“We are pleased that the FDA awarded Aptus Endosystems with clearance of this longer reach guide catheter. This clearance combined with the recent pre-launch of our Heli-FX Thoracic System speaks volumes about the Aptus team’s ability to quickly respond to physician needs and to meet the challenges they face when treating aortic aneurysm disease,” said James Reinstein, chief executive officer of Aptus Endosystems.