November 12, 2018
Medtronic Receives CE Mark Approval for the Valiant Navion Thoracic Stent Graft System
November 13, 2018—Medtronic announced that it has received CE Mark approval for the Valiant Navion thoracic stent graft system for the endovascular repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAAs), blunt traumatic aortic injuries, penetrating atherosclerotic ulcers (PAUs), intramural hematomas, and type B aortic dissections. In October, the company announced FDA approval of the Valiant Navion system.
The Valiant Navion system is a lower-profile evolution of Medtronic's Valiant Captivia thoracic stent graft system and features the company's CoveredSeal (proximal covered) and FreeFlo (proximal bare-metal) stent configurations, both with tip-capture accuracy, to provide two graft options to treat varying patient anatomies and pathologies.
According to the company, European approval was based on 30-day primary endpoint analysis of 87 patients consecutively enrolled in the international, multicenter, prospective investigational device exemption (IDE) study analyzing the safety and efficacy of Valiant Navion in patients with TAA and PAU.
The results demonstrated efficacy in both FreeFlo and CoveredSeal configurations, with no instances of access or deployment failures at the implant in the full study cohort. Through 30 days, data showed low rates of perioperative mortality at 2.3% and secondary procedures at 2.3%. The rate of type Ia endoleaks was 1.2% at 1-month imaging follow-up.
In Medtronic's announcement, Professor Fabio Verzini, MD, who serves as European principal investigator for the Valiant Navion IDE study, commented, "In clinical practice, we often see patients with a wide range of thoracic aortic anatomies. For example, thoracic endovascular aortic repair (TEVAR) in females doubles the risk of needing an adjunctive iliac access procedure, which can potentially add risk, time, and cost to the procedure. The approval of Valiant Navion gives us the ability to broaden the treatable patient population with thoracic aortic disease, including more female patients and those who were previously considered ineligible for TEVAR with a percutaneous approach." Prof. Verzini, is Associate Professor of Vascular Surgery at University of Turin, Italy.