Transcatheter Pulmonary Valve Gets European Approval

Medtronic announced CE Mark approval for its transcatheter pulmonary valve replacement technology in Europe today. From their press release:

Transcatheter valve technology represents a less invasive means to treat heart valve disease and is designed to allow physicians to deliver replacement valves via a catheter through the body’s cardiovascular system, thus eliminating the need to open the chest. Traditionally, open heart surgery has been required to correct the problem and it is not unusual for a patient to undergo multiple, open-heart surgeries during their lifetime. Patients with this condition tire very easily, as the heart over-exerts itself trying to get oxygenated blood throughout the body.

Medtronic has partnered with Professor Philipp Bonhoeffer, professor and chief of cardiology and director of the Catheterization Laboratory, Great Ormond Street Hospital for Children (GOSH) in London, and NuMed, a pediatric catheter company in the development of the Melody Valve and Ensemble System. A pioneer in transcatheter valve technology, Professor Bonhoeffer implanted the world’s first transcatheter valve in September 2000. To date, more than 150 patients worldwide have been implanted with the Melody Transcatheter Pulmonary Valve.

CE Mark Approval gives Medtronic the ability to train and educate physicians in Europe in preparation for implanting the Melody™ and Ensemble™ System so that more patients can benefit from this innovative treatment. With proper training in place, Medtronic will work with hospitals across Europe in gaining access to this new technology.

Look for more and more trancatheter valve replacement technologies to enter the field of cardiology soon. Aortic valve replacement technologies, mitral valve repair technologies, and others are also on the horizon. Cardiothoracic surgeons aren't happy about these, but the need to repair failed implants will still exist as these devices gain popularity.

--Wes