Endospan’s Nexus Aortic Arch Stent Graft System Evaluated in Initial Experience

November 1, 2021—Endospan announced the publication of the 30-day and 1-year performance and safety outcomes of the company’s off-the-shelf endovascular Nexus aortic arch stent graft system in the treatment of thoracic aortic lesions involving the aortic arch.

“Nexus Arch: A Multicenter Study Evaluating the Initial Experience with a Novel Aortic Arch Stent Graft System” was published by David Planer, MD, et al and is available online ahead of print in Annals of Surgery.

According to the company, the cohort includes 28 patients in a prospective single-arm clinical study—either the first-in-man study or the compassionate-use systematic data collection study.

“The aortic arch repair remains the most challenging for both open cardiac surgery and endovascular repair,” commented Dr. Planer in the company’s press release. “The high procedural success rate at 30 days without reports of aneurysm-related mortality, disabling stroke, or device failure at 1 year, confirms the safety and effectiveness of the Nexus device in this high-risk patient population.” Dr. Planer is from Hadassah—Hebrew University Medical Center in Jerusalem, Israel.

Endospan’s Nexus device is currently available for sale in Europe. In the United States, it is intended for investigational use only, advised the company. Endospan is headquartered in Tel Aviv, Israel.

Kevin Mayberry, CEO of Endospan, stated in the announcement, “The Nexus aortic arch stent graft system is the first CE-certified, off-the-shelf double stent graft system, developed specifically to address the morphology and hemodynamic challenges of the aortic arch and to mitigate the risk of stroke. This landmark publication is encouraging for the outcomes in the TRIOMPHE investigational device exemption study currently enrolling towards United States approval for the Nexus aortic arch repair stent graft system.”