Medtronic Begins Real-World Post-Market Study of the Valiant Navion Thoracic Stent Graft System in Patients with Thoracic Aortic Dissection

Global “DISSECT-N” Post-Market Study to Broaden Evidence Base for Safety and Effectiveness of Commercially Available Endovascular Repair Technology 

DUBLIN, July 06, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the start of a prospective, observational, global, multi-center, real-world, post-market study to evaluate the safety and effectiveness of the Valiant Navion Thoracic Stent Graft System in the treatment of thoracic aortic dissection. The first patient procedure in the DISSECT-N study was performed at Northwell Health in New York, New York by Derek Brinster, M.D., director of Aortic Surgery.

“Treatment of aortic dissection is often challenging, especially as patients with fragile aortas have different needs. The Valiant Navion CoveredSeal configuration, designed with fragile aortic tissue in mind, can be especially helpful in treating this condition,” said Ross Milner, M.D., director of the Center for Aortic Diseases at the University of Chicago Medicine in Chicago and U.S. principal investigator for the DISSECT-N study. “I believe the DISSECT-N study — one of the larger prospective aortic dissection repair studies, which includes independent core-lab imaging review — will offer critical contemporary insights about TEVAR use in patients with various types of thoracic aortic dissection.”

The DISSECT-N study will enroll at least 200 patients with an acute or chronic thoracic aortic dissection across approximately 45 sites in North America, Europe, and Asia Pacific. The primary endpoint is composite safety and effectiveness, including technical procedure success and freedom from major adverse events (MAEs) reported up to one month following the index procedure. Patients will be followed for three years. Primary investigators are Dr. Milner and Robin Heijmen, M.D., Ph.D., cardiothoracic surgeon at St. Antonius Hospital in the Netherlands.

“Thoracic aortic dissection is dangerous, with some cases leading to severe internal bleeding or irreversible organ damage; with the Valiant Navion system, more patients with aortic dissection are eligible for thoracic endovascular aneurysm repair (TEVAR),” said Dr. Heijmen, European principal investigator for the DISSECT-N study. “I am pleased to support the generation of real-world evidence in this landmark study, which I believe will help enable the clinical community to optimally treat patients with thoracic aortic dissection using this technology.”