Aptus Endosystems, Inc., a medical device company developing advanced technology for endovascular aneurysm repair (EVAR), announced today that its ANCHOR post-market registry enrollment has surpassed its key milestone of 250 patients.
ANCHOR ( An eurysm Treatment Using the H eli-FX™ A o rtic Securement System Global R egistry), a global, multicenter, prospective post-market registry, evaluates the use of the Heli-FX™ System in EVAR and captures critical data on use of the technology and acute and long term procedural outcomes. The proprietary helical anchor technology, also called an “EndoAnchor,” enables independent endograft fixation and sealing, and is designed to replicate hand suturing performed during open surgical repair of aneurysms.
“As the use of this new tool to secure endografts becomes more widespread, we are gaining scientific validity of these results in the real world setting. Clinicians from around the world are contributing their experiences to help us understand the best application of the Heli-FX System,” said William Jordan, M.D., Chief, Section of Vascular Surgery at the University of Alabama Hospital, Birmingham, Ala., and Principal Investigator for ANCHOR in the United States.
“The ANCHOR Registry will provide real world data to substantiate the benefits of the Heli-FX System,” 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. “This data will give us answers regarding the prevention of neck dilatation post-EVAR.” “The rapid acceptance of the Heli-FX technology by the ANCHOR investigators allowed us to reach this 250 patient milestone well ahead of our plans,” said James Reinstein, President and CEO of Aptus Endosystems, Inc. “We are impressed by the early technical success of the technology. Our expectation is to see a reduction in secondary interventions when EndoAnchors are used in these difficult to treat anatomies.” Aortic aneurysms are an enlarged and weakened section of the aorta, the main artery carrying blood from the heart, which can be lethal if left untreated. Each year, an estimated 200,000 people in the U.S. and 100,000 people in Europe are diagnosed with abdominal aortic aneurysms (AAA). In EVAR and thoracic endovascular aneurysm repair (TEVAR), an alternative to open surgical repair of aortic aneurysms, a minimally invasive catheter-based system is used to implant a metal and fabric endograft to isolate blood flow away from the aneurysm to prevent potential rupture and death. The innovative helical anchor technology of the Heli-FX system enables independent endograft fixation and sealing, and is designed to replicate hand suturing performed during open surgical repair of aneurysms.
The Heli-FX system can be used during primary EVAR procedures to enhance an endograft’s inherent fixation and sealing mechanisms. 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, which are often seen after EVAR. In such cases, augmented fixation and/or sealing is required to regain or maintain effective aneurysm exclusion.
“The ANCHOR findings suggest that the Aptus device will play a prominent role in the treatment of AAA, expanding the number of patients who may be treated with a minimally-invasive solution and providing a suitable option for those with a previously placed endograft that has developed a leak or migration,” said Kenneth Ouriel, M.D., former Chief of Surgery at Cleveland Clinic.
