Medtronic's ESAR and Valiant efficacy and safety results presented in London
Medtronic presented new data at the Charing Cross Symposium in London on endovascular repair of abdominal aortic aneurysm, or AAA, patients with the Endurant II/IIs stent graft system in combination with Heli-FX EndoAnchor implants and for the Valiant Navion thoracic stent graft system for thoracic endovascular repair, or TEVAR. Medtronic shared preliminary two-year data supporting the safety, durability, and effectiveness of Endurant to treat AAA patients with short aortic necks when used in combination with the Heli-FX EndoAnchor system. One-year outcomes from 70 patients enrolled with short infra-renal necks showed that hrough two years, freedom from aneurysm-related mortality was 94.3% and freedom from secondary endovascular procedure was 95.5%. Finally, no AAA ruptures or stent graft main body migrations were reported through two years. New data from the full patient cohort of the pivotal Valiant Navion study were also presented analyzing the safety and efficacy of Valiant Navion in subjects with thoracic aortic aneurysm and penetrating atherosclerotic ulcer. The results demonstrated safety and 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 2.0% and secondary procedures at 2.0%. The rate of Type Ia endoleaks was 1.1% at one-month imaging follow-up.