Myval™ Octacor Transcatheter Heart Valve System - Aortic transcatheter heart valve bioprosthesis, stent-like framework

Intended purpose

The Myval™ Octacor Transcatheter Heart Valve System (THVS) is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis as judged by a heart team (including a cardiac surgeon) and in patients who are at a risk for open heart surgical therapy (Society of Thoracic Surgeons operative risk score of 4% risk of mortality at 30 days).

Functional description

The Myval™ Octacor transcatheter heart valve (THV) system consists of the Myval™ Octacor THV, Delivery System, Balloon Dilatation Catheter, Introducer Set, and Crimping Tool. The balloon-expandable THV consists of a) a frame of cobalt-nickel-chromium-molybdenum alloy, b) a tri-leaflet fixed bovine pericardium tissue valve and c) inner and outer fabric covers. The THV system accessories facilitate the implantation of the bioprosthesis by balloon expansion.