Aptus Endosystems announced the successful treatment of the first series of patients in the United States with the HeliFX aortic securement system after having received FDA clearance on 21 November.
The innovative helical anchor technology enables independent endograft fixation to the aorta, and is designed to mimic the hand suturing performed during open surgical repair of abdominal aortic aneurysms. In the first few weeks since regulatory clearance, physicians have already used the HeliFX system in both de novo EVAR procedures as well as in secondary interventions, and with several different manufacturers’ endografts – all in cases where the physicians believed that long term patient outcomes would be improved with augmented fixation and sealing of the endograft with the HeliFX EndoAnchors.
“Technology such as the HeliFX system has long been overdue,” said Venkatesh Ramaiah, director of Peripheral Vascular Surgery and Endovascular Research at the Arizona Heart Institute, Phoenix, USA, who performed one of the first procedures. “We are often faced with high surgical risk patients with challenging anatomy who require improved fixation and sealing for long term durability. I found the EndoAnchor deployment to be easy and highly accurate despite difficult anatomy. We were able to treat an angulated and conical proximal neck, and also correct an intra-operative Type 1 endoleak – all in a patient who had limited treatment alternatives.”
“It was great to be able to use the HeliFX EndoAnchors,” said William Jordan, chief Section of Vascular Surgery at the University of Alabama Hospital, Birmingham, USA, who performed the procedure on two patients. “This advance offers us a means to securely fix aortic endografts when treating anatomically challenging patients. It is the right technology at the right time.”
“The HeliFX system is a game-changing technology that will allow us to safely and effectively offer stent graft therapy to a much broader population of patients,” said James Joye, director of Research, Education, and Interventional Services at the Heart & Vascular Institute of El Camino Hospital in Mountain View, California, USA. “In our first application of this intuitive device we were able to treat a patient with a short, angulated infrarenal neck who otherwise was bound for open surgical repair. The EndoAnchor resolved a Type I endoleak immediately, and left me with the security and confidence that I would not have to worry about endograft migration in the years to come.”
“Completing our first series of HeliFX cases in the United States marks the beginning of a new chapter for EVAR, and we are privileged to work with well-regarded thought leaders such as Drs. Ramaiah, Jordan, Joye, and others,” said Jeff Elkins, CEO of Aptus Endosystems. “This initial US experience supports the ease of use and procedural success that we have seen with the HeliFX system in Europe. The novel concept of independent and physician-controlled proximal fixation using EndoAnchors represents a considerable step toward addressing and preventing long-term complications and making EVAR the definitive solution for treating aortic aneurysms.”