Medtronic's non-surgery replacement heart valve approved by FDA
Posted on 03/02/2010 in Medical Company Product News
Medtronic has announced that the Food and Drug Administration (FDA) granted it approval to market the Melody Transcatheter Pulmonary Valve - a piece of equipment which can be installed without the need for major surgery.
Marking the first time a transcatheter heart valve has received FDA approval, the firm claimed that the Melody device will benefit both children and adults who are born with malformations of their pulmonary valve.
The Melody product became the first transcatheter valve in the world to receive regulatory approval after receiving the CE mark in October 2006.
Dr John Liddicoat, vice-president and general manager of the Structural Heart division - part of the company's cardiovascular business - said: "Medtronic is leading the development of transcatheter therapies for heart valve disease. FDA approval of the Melody Transcatheter Pulmonary Valve is evidence of that leadership."
Last month, the organisation asked long-distance runners from across the globe who use medical devices to help it develop new technologies by participating in the Medtronic Twin Cities Marathon or the Medtronic TC 10 Mile event.