VASCULAR INNOVATIONS Hydra Transcatheter Aortic Valve System

The Hydra Valve system is indicated for patients with severe symptomatic degenerative aortic stenosis presenting a high predictable operative mortality risk for surgical aortic valve replacement and therefore is referred to transcatheter aortic valve implantation. The decision is based on the clinical judgment of the Heart Team. The Hydra valve transcatheter aortic valve implantation necessitates valve replacement of the native aortic heart valve without open heart surgery and without concomitant surgical removal of the failed native valve and presenting with femoral access vessels with diameters ≥ 5mm for 22 mm & 26mm heart valve and ≥ 5.5mm for 30mm heart valve and anatomical dimensions of the aortic annulus diameter between 18mm to 27mm.