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August 17, 2020

FDA Approves IDE for Pivotal TRIOMPHE Study of Endospan’s Nexus Aortic Arch Stent Graft System

August 17, 2020—Endospan announced it received FDA approval for an investigational device exemption (IDE) to start the TRIOMPHE study on the company’s Nexus aortic arch stent graft system.

The prospective and multi-arm pivotal TRIOMPHE IDE study will enroll patients at up to 30 centers to evaluate the safety and effectiveness of the Nexus for the endovascular treatment of thoracic aortic lesions involving the aortic arch including chronic dissections, aneurysms, penetrating aortic ulcers, and intramural hematoma.

The national coprincipal investigators for TRIOMPHE study are Ross Milner, MD, and Brad Leshnower, MD. Dr. Milner is Professor of Surgery, Co-Director, Center for Aortic Diseases at the University of Chicago in Chicago, Illinois. Dr. Leshnower is Associate Professor of Surgery, Division of Cardiothoracic Surgery, Department of Surgery, at Emory University School of Medicine in Atlanta, Georgia.

“The TRIOMPHE pivotal study will assess the Nexus in some of the most challenging aortic arch pathologies that we encounter,” commented Dr. Milner in Endospan's announcement. “For the patient, there are limited options to treat these life-threatening pathologies. The Nexus device is designed to address most of those complexities through a minimally invasive approach with the potential to provide a safe and durable solution.”

Dr. Leshnower stated, “There are a significant number of patients who are too high risk for open surgical treatment who are also at significant risk from their aortic arch disease. The Nexus provides an innovative minimally invasive option, which provides cardiac surgeons, if proven safe and effective, the potential to save the lives of patients who would have previously had no other treatment options available.”

On April 20, Endospan advised that the FDA granted a breakthrough device designation for the Nexus. European CE Mark approval for the device was announced in March 2019.

The Nexus aortic arch stent graft system is currently available for sale in Europe. In the United States, it is intended for investigational use only.

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