July 6, 2020
Medtronic Begins Global DISSECT-N Postmarket Study of the Valiant Navion System for Thoracic Aortic Dissections
July 6, 2020—Medtronic announced the start of DISSECT-N, a prospective, observational, global, multicenter, real-world, postmarket study to evaluate the safety and effectiveness of the company's Valiant Navion thoracic stent graft system in the treatment of thoracic aortic dissection. The first patient procedure in the study was performed by Derek Brinster, MD, Director of Aortic Surgery at Northwell Health in New York, New York.
According to Medtronic, 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 the Asia Pacific. The primary endpoint is composite safety and effectiveness, including technical procedure success and freedom from major adverse events, reported up to 1 month following the index procedure. Patients will be followed for 3 years.
The DISSECT-N study's primary investigators are Ross Milner, MD, in the United States, and Robin Heijmen, MD, in Europe. Dr. Milner is Director of the Center for Aortic Diseases at the University of Chicago Medicine in Chicago, Illinois. Dr. Heijmen is a cardiothoracic surgeon at St. Antonius Hospital in Utrecht, the Netherlands.
“Treatment of aortic dissection is often challenging, especially as patients with fragile aortas have different needs,” commented Dr. Milner in the company's announcement. “The Valiant Navion CoveredSeal configuration, designed with fragile aortic tissue in mind, can be especially helpful in treating this condition. 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 [thoracic endovascular aortic repair] use in patients with various types of thoracic aortic dissection.”
Dr. Heijmen added, "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. 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.”
In October 2018, Medtronic announced FDA approval for the low-profile Valiant Navion system. European CE Mark approval was announced in November 2018. The company announced approval in Japan in September 2019.