The Melody™ transcatheter pulmonary valve (TPV) is specifically designed to treat right ventricular outflow tract (RVOT) dysfunction in conduits and dysfunctional bioprosthetic pulmonary valves. It is comprised of a bovine jugular vein (BJV) valve sutured within a platinum-iridium frame.
The Ensemble™ II transcatheter delivery system is designed for controlled, stepwise deployment of the valve with balloon-in-balloon technology.Product Details
Harmony™ transcatheter pulmonary valve technology is a non-surgical option designed to treat severe pulmonary regurgitation in patients with a native or surgically-repaired right ventricular outflow tract (RVOT). It is comprised of a porcine pericardial tissue valve sewn in a self expanding nitinol frame with a polyester cloth covering.
The Harmony system facilitates predictable device deployment in the intended position.1Product Details
Based on internal test report #D00177328, Human factors engineering summative and usability design validation test report. Bench testing may not be representative of clinical performance. Bench testing performed in simulated anatomical fixture.