Medtronic received FDA approval for its Valiant Navion thoracic stent graft, a minimally invasive system for correction of lesions within the descending thoracic aorta, particularly in patients with narrow iliac arteries. The device is indicated in thoracic aortic aneurysms (TAA), blunt thoracic aortic injuries, penetrating atherosclerotic ulcers, intramural hematomas, and aortic type B dissections.
Patients with small iliac arteries were typically poor candidates for thoracic endovascular aneurysm repair, sometimes requiring additional procedures just to get started or more commonly having to go with open surgery.
The Valiant Navion is based on the already popular Valiant Captivia thoracic stent graft system, but featuring a narrower profile for easier navigation through challenging anatomy. It comes with two different stent configurations: CoveredSeal (proximal covered) and FreeFlo (proximal bare metal). These two options give physicians an ability to treat a wide range of patients.
Some details about the study that led to the approval, according to Medtronic:
Approval was based on 30-day primary endpoint analysis of 87 subjects consecutively enrolled in the international, multicenter, prospective investigational device exemption (IDE) study analyzing the safety and efficacy of Valiant Navion in subjects with TAA and PAU. The study included a challenging real-world patient population with 37.9 percent female enrollment and 71.3 percent subjects with severe to life-threatening systemic disease (ASA physical status classification III/IV). The results demonstrated efficacy, with:
– FreeFlo configuration implanted in 74.7 percent of procedures with no instances of access or deployment failures at implant in the full study cohort.
– The new CoveredSeal proximal configuration implanted in 25.3 percent of procedures with no instances of access or deployment failures at implant in the full study cohort.
The majority of procedures (50.6 percent) were performed through a percutaneous access approach, leading to operational efficiency with mean procedure and fluoroscopy times of 88.7 ± 53.4 minutes and 12.2 ± 8.8 minutes, respectively.
Through 30 days, data showed low rates of peri-operative mortality at 2.3 percent (2/87) and secondary procedures at 2.3 percent (2/87). The rate of Type Ia endoleaks was 1.2 percent (1/87) at one-month imaging follow-up.