TRANSCATHETER PULMONARY VALVES (TPV) HEALTHCARE PROFESSIONALS

HARMONY™ TPV AND DELIVERY CATHETER SYSTEM

Harmony transcatheter pulmonary valve (TPV)

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 sown 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

MELODY™ TPV/ENSEMBLE™ II DELIVERY SYSTEM

Melody TPV Ensemble II Transcatheter Pulmonary Valve System

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
1

Medtronic data on file. Human Factors Engineering Summative and Usability Design Validation Test Report - D00177328. Bench testing may not be representative of clinical performance. Bench testing performed in simulated anatomical fixture.