ANCHOR Postmarket Registry Will Evaluate Aptus' HeliFX

February 14, 2012—Aptus Endosystems, Inc. (Sunnyvale, CA) announced the start of the ANCHOR postmarket registry, which will evaluate the use of the company's HeliFX aortic securement system.

The company announced in November 2011 that it received 510(k) clearance from the US Food and Drug Administration for the HeliFX system for use during endovascular aneurysm repair (EVAR).

According to the company, the device's EndoAnchor helical anchor technology enables independent endograft fixation to the aorta and mimics the suturing performed during open surgical repair of abdominal aortic aneurysms.

The global, multicenter, prospective ANCHOR registry will collect data on the treatment of abdominal aortic aneurysms and provide clinical knowledge for the optimal use of the HeliFX system. The registry will consist of two arms, “Primary” and “Revision,” which support the indications for use of the HeliFX system with commercially available endografts manufactured by Cook Medical (Bloomington, IN), Gore & Associates (Flagstaff, AZ), and Medtronic, Inc. (Minneapolis, MN).

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.

The registry will enroll up to 1,000 patients at up to 75 sites in the United States and Europe in each arm of the registry. Patient data will be followed for up to 5 years. William Jordan, MD, and Jean Paul de Vries, MD, are the registry's Principal Investigators in the United States and Europe, respectively, stated the company.

“The ANCHOR registry will prioritize the incremental value of the use of EndoAnchors in de novo EVAR patients with challenging proximal aortic neck anatomies that can lead to migration and type I endoleaks,” commented Dr. de Vries. “Moreover, EndoAnchors have been shown to be safe and feasible in revision surgery post- EVAR to solve inadequate proximal fixation and seal of endografts. The ANCHOR registry will provide us with valuable longer-term data concerning improvement of endograft adaptation to the aortic wall.”