CE mark approval has been granted for the Valiant Navion thoracic stent graft system (Medtronic) for the minimally invasive repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAA), blunt traumatic aortic injuries (BTAI), penetrating atherosclerotic ulcers (PAU), intramural hematomas (IMH), and type B aortic dissections (TBAD). This follows the recent US FDA approval of the Valiant Navion system.
“In clinical practice we often see patients with a wide range of thoracic aortic anatomies. For example, TEVAR in females doubles the risk of needing an adjunctive iliac access procedure, which can potentially add risk, time, and cost to the procedure,” says Fabio Verzini, associate professor of Vascular Surgery, University of Turin, Italy and European principal investigator for the Valiant Navion IDE study. “Approval 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.”
Medtronic says that the system is a lower-profile evolution of the market-leading Valiant Captivia thoracic stent graft system, which has treated more than 100,000 patients globally. It is built on the design philosophy of the Valiant Captivia system for improved performance and increased patient applicability. The system also features the CoveredSeal (proximal covered) and FreeFlo (proximal bare metal) stent configurations—both with tip-capture accuracy, providing physicians with two graft options to treat varying patient anatomies and pathologies.
Approval was based on 30-day primary endpoint analysis of 87 patients consecutively enrolled in the international, multicentre, prospective investigational device exemption (IDE) study analysing 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 implant in the full study cohort. Through 30 days, data showed low rates of peri-operative mortality at 2.3% and secondary procedures at 2.3%. The rate of Type Ia endoleaks was 1.2% at one-month imaging follow-up.