New Products In Brief
This article was originally published in The Gray Sheet
Executive Summary
Canada OKs transcatheter valve: Medtronic receives a medical device license from Health Canada for its Melody transcatheter pulmonary valve and Ensemble transcatheter delivery system on Jan. 10. The catheter-based therapy system is the first of its kind to treat patients with congenital and acquired structural heart disease, Medtronic says. The Melody valve and Ensemble system offer a nonsurgical means to restore effective valve function and prolong the life of prosthetic conduits, reducing the need for open heart surgeries. The device received a CE mark in 2006. Medtronic is in discussions with FDA on the design of a trial to support a PMA...