Endospan’s Nexus Arch Branch Stent Graft System Studied at 2 Years
November 5, 2019—VIVA Physicians announced that 2-year results from a prospective, multicenter, premarket study composed of 25 patients (mean age, 73 years) treated with the Nexus aortic arch stent graft (Endospan) were presented by Daniel Clair, MD, in a late-breaking clinical trial session at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.
The Nexus device, which received European CE Mark approval in March 2019, is an off-the-shelf system for endovascular treatment of pathologies extending or involving the aortic arch.
In the study, all patients had aneurysm size > 55 mm and were considered high risk for conventional open arch surgery by a multidisciplinary team. Indications for treatment were aneurysm (15 [60%] patients) or dissection (10 [40%] patients), including seven patients previously treated surgically for type A dissection. Thirteen (52%) patients had previous thoracic aortic surgery. Supra-aortic bypasses were performed before Nexus implantation.
Dr. Clair reported that technical success was achieved for all intended Nexus introductions and deployments (100%). At 30 days, two (8%) patients died from cardiac causes and two (8%) patients showed nondisabling stroke, which resolved completely within 30 days.
During a mean follow-up of 25 months, there was one additional procedure-related mortality from stroke, and one patient was converted to open surgery after retrograde type A dissection. During follow-up, aneurysm size decreased or remained stable in 96% of patients, with no aneurysm-related deaths.
These midterm results at a mean 25-month follow-up are stable without any material failure or stent graft issues; however, more experience and longer follow-up are necessary to confirm these promising midterm results, concluded Dr. Clair.
As noted in the VIVA announcement, the Nexus’s modular stent graft is introduced via a 20-F delivery system with double flushing ports, which allows efficient de-airing. The main module is deployed over an axillofemoral guidewire to extend from the brachiocephalic trunk to the descending aorta and is combined with a precurved ascending module that conforms to the ascending aorta.
The Nexus branched stent graft, which is specifically designed for the aortic arch, includes features that assist in minimizing manipulations. This may explain the high technical success, low rate of neurologic complications, and durability, allowing safe endovascular repair, noted Dr. Clair.