Aptus Endosystems has announced that its ANCHOR post-market registry enrolment has surpassed its key milestone of 250 patients.
ANCHOR (Aneurysm treatment using the Heli-FX aortic securement system global registry), a global, multicentre, prospective post-market registry, is expected to evaluate 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. According to the company, 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.
“The ANCHOR registry will provide real world data to substantiate the benefits of the Heli-FX System,” said Jean Paul de Vries, 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. “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.”
The Heli-FX system can be used during primary EVAR procedures to enhance an endograft’s inherent fixation and sealing mechanisms, according to a press release. 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 ANCHOR findings suggest that the Aptus device will play a prominent role in the treatment of abdominal aortic aneurysms. 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, former Chief of Surgery at Cleveland Clinic, USA.