Medical technology firm Medtronic has secured CE mark approval for its Valiant Navion thoracic stent graft system.
The Valiant Navion system has been approved 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).
The US Food and Drug Administration recently approved the Valiant Navion system, which is a lower-profile transformation of the Valiant Captivia thoracic stent graft system that was used to treat more than 100,000 patients across the globe.
Valiant Navion IDE study European principal investigator professor Fabio Verzini said: “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 procedure1, which can potentially add risk, time, and cost to the procedure.”
The Valiant Navion system is provided with CoveredSeal (proximal covered) and FreeFlo (proximal bare metal) stent configurations, offering physicians with two graft options to treat varying patient anatomies and pathologies.
The CE mark approval was based on 30-day primary endpoint analysis of 87 subjects consecutively recruited in the international, multicenter and prospective investigational device exemption (IDE) study.
The study analyzed the safety and efficacy of Valiant Navion in subjects with TAA and PAU.
According to the company, the results showed efficacy in both FreeFlo and CoveredSeal configurations with no incidences of access or deployment failures at implant in the full study cohort.
Medtronic cardiac and vascular group’s aortic business general manager and vice president John Farquhar said: “In just a few short weeks, we have achieved significant momentum with Valiant Navion – obtaining both FDA and CE Mark approvals.
“We’re proud to introduce the Valiant Navion system in Europe and believe in its potential to expand treatment options for physicians and patients with thoracic aortic disease.”