FDA Clearance for HeliFX Guide for Wide-Neck AAA

On May 28, 2013, Aptus Endosystems announced that its 28-mm Tip Reach HeliFX Guide had received FDA 510(k) clearance for treatment of wide-neck abdominal aortic aneurysms (AAAs). The device was on display at the Society for Vascular Surgery 2013 Annual Meeting in San Francisco last week as well.

“The longer reach 28 mm 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 HeliFX system especially when treating difficult aortic anatomy,” said William P. Jordan, MD, Chief, Section of Vascular Surgery at the University of Alabama Hospital, Birmingham, Alabama, in a press release from Aptus Endosystems.

This month, editor-in-chief Frank Criado, MD, FACS, FSVM, discusses this development on “Vascular Access: the VDM Clinician Blog:”

I am personally convinced endoanchors (“endo-sutures”) constitute a long-awaited addition to the endovascular toolbox and will undoubtedly prove their utility. That said, however, we must not deviate from the concept that endostaples are meant to enhance graft fixation to the aortic wall. And while it is true they can also contribute to achieving a good seal, this requires the implantation of a large number of such staples that are also very close to one another – much the same as one would do with surgical sutures. It is also important to remember that we currently have little if any data at all to guide applicability of these devices or attest to their effectiveness.

A clinical registry trial, the ANCHOR (Aneurysm Treatment using the HeliFX Aortic Securement System Global Registry), is currently recruiting participants and will collect data on the treatment of AAAs for optimal use of the HeliFX system. Two registry arms will support the indications for use of the HeliFX system with commercially available endografts manufactured by Cook Medical, W.L. Gore, and Medtronic. The “Primary” group will characterize the HeliFX system placed at the time of endograft implantation for the prevention of graft migration and Type 1 endoleak. The “Revision” group will characterize the HeliFX system in patients with previously implanted endografts that require treatment for graft migration and Type 1 endoleaks. As many as 75 sites across the United States and Europe may enroll up to 1,000 patients in each arm of the registry. Patient data will be followed for up to 5 years.

Read more from Dr. Criado in “Endostapling News: All Good (I Think).

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