Thirty-Day Safety and Efficacy Data Presented for Medtronic's Valiant Navion TEVAR System
April 17, 2019—Medtronic announced the presentation of new data for its Valiant Navion thoracic stent graft system for thoracic endovascular aneurysm repair (TEVAR). The 30-day full patient cohort from the Valiant Navion investigational device exemption (IDE) study were presented by European Principal Investigator Professor Fabio Verzini, MD, at the Charing Cross Symposium, held April 15–18 in London, United Kingdom.
The international, multicenter, prospective IDE study is analyzing the safety and efficacy of the Valiant Navion thoracic stent graft system in 100 patients with thoracic aortic aneurysm and penetrating atherosclerotic ulcer.
According to Medtronic, the results demonstrated safety and efficacy in both FreeFlo and CoveredSeal configurations, with no instances of access or deployment failures at implantation in the full study cohort. Through 30 days, data showed low rates of perioperative mortality at 2.0% and secondary procedures at 2.0%. The rate of type Ia endoleaks was 1.1% at 1-month imaging follow-up.
The Valiant Navion system is a lower-profile evolution of Medtronic's Valiant Captivia thoracic stent graft system. The company noted that Valiant Navion is designed for improved flexibility and conformability, as well as increased patient applicability to address multiple challenging pathologies of the thoracic aorta. The system also features the CoveredSeal (proximal covered) and FreeFlo (proximal bare metal) stent configurations, both with tip-capture accuracy. The low-profile device is also designed to treat underlying pathologies while minimizing the potential impact to the aortic wall, particularly in fragile aortas.
In October 2018, Medtronic announced FDA approval for the Valiant Navion system for TEVAR of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms, blunt thoracic aortic injuries, penetrating atherosclerotic ulcers, intramural hematomas, and type B aortic dissections. In November, the company announced European CE Mark approval for the device.