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.

Approximately six out of 100,000 people globally experience a thoracic aortic aneurysm (TAA), a blood-filled bulge or ballooning of the aorta that runs through the chest and can lead to a life-threatening rupture and hemorrhage if not treated. Most people with TAA do not have any symptoms; however, risk factors include smoking, obesity, heredity, injury, or other disease.

In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.


About Medtronic
Medtronic plc, headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 86,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

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