Aptus Endosystems Initiates the ANCHOR Post-Market Registry
Global registry will assess best clinical practices with the innovative HeliFX Securement System
Sunnyvale, CA, February 14, 2012—Aptus Endosystems Inc., a medical device company developing advanced technology for endovascular aneurysm repair (EVAR), announced the start of ANCHOR, a global, multicenter, prospective post-market registry, which will evaluate the use of the HeliFX™ Aortic Securement System in the treatment of aortic aneurysms. The proprietary helical anchor technology, also called an “EndoAnchor”, enables independent endograft fixation to the aorta, and mimics the suturing performed during open surgical repair of abdominal aortic aneurysms (AAAs).
ANCHOR (Aneurysm Treatment using the HeliFX™ Aortic Securement System Global Registry) will collect data on the treatment of AAAs and provide the clinical knowledge for optimal use of the HeliFX system in the setting of clinical practice. 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, 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 five years.
“The ANCHOR registry provides a great opportunity for physicians to evaluate the novel HeliFX Aortic Securement System which has the potential to improve the long-term durability of EVAR in clinical practice,” said William Jordan, M.D., Chief, Section of Vascular Surgery at the University of Alabama Hospital, Birmingham, and Principal Investigator for ANCHOR in the United States.
“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,” said Jean Paul de Vries, M.D., Ph.D., Head of the Department of Vascular Surgery at St. Antonius Hospital, Nieuwegein, The Netherlands, and Principal Investigator for ANCHOR in Europe. “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.”
“The Company is privileged to be working with many leading EVAR investigators in the U.S. and Europe on this important, first-of-its type clinical program focused on EndoAnchors as an adjunct to leading commercially available endografts,” said Jeff Elkins, President and CEO of Aptus. “The ANCHOR registry represents Aptus’ commitment to responsibly advancing clinical research and data dissemination for this exciting new technology. Proactively gathering acute and long-term post-market data from the earliest stages of commercial release will help to maximize the clinical understanding of the varied HeliFX applications, capabilities, and potential clinical and economic benefits.”
About Aptus Endosystems, Inc.
Headquartered in Sunnyvale, Calif., Aptus Endosystems is a privately held medical device company focused on developing advanced technology for endovascular aneurysm repair (EVAR). An estimated 1.5 million Americans have an abdominal aortic aneurysm (AAA), which can be life-threatening if left untreated and approximately 200,000 people are newly diagnosed each year. Aptus Endosystems has developed a unique endograft and innovative helical anchor technology that allows physicians to perform minimally invasive EVAR while still providing the control and potential long term durability of an open surgical repair. The Fortevo™ AAA Endograft System and the HeliFX Aortic Securement System bear the CE Mark for distribution in the European Union. The HeliFX Aortic Securement System is cleared by the FDA for distribution in the United States. The Fortevo AAA Endograft System is Investigational Use Only in the United States. For more information, please visit www.aptusendosystems.com.
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Media ContactAptus Endosystems, Inc.
Jeff Elkins, CEO
Ph: (408) 530-9050