Transcatheter pulmonary valves (TPV) Healthcare professionals

Melody TPV/Ensemble II Delivery System

Melody transcatheter pulmonary valve (TPV) with Ensemble II delivery system on white background

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.

Indications, Safety, and Warnings

Product Details

Harmony TPV and Delivery Catheter System

Harmony transcatheter pulmonary valve (TPV) on transparent background

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.1

Indications, Safety, and Warnings

Product Details

Reference

1

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.