News | February 22, 2007

Now in Trial, Catheter-Based Device May Reduce Number of Surgeries for Congenital Heart Patients

Feb. 23, 2007 — The first patient implant was performed this week in a feasibility study evaluating the use Medtronic’s Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System to treat patients requiring congenital pulmonary heart valve replacement.

The prospective, non-randomized, feasibility clinical trial will enroll 30 patients at three U.S. medical centers including:

• Children's Hospital Boston (Boston, MA) with investigators James Lock, M.D. Cardiologist-in-Chief and Emile Bacha, M.D. Senior Associate in Cardiac Surgery

• Morgan Stanley Children's Hospital of New York - Presbyterian (New York, NY) with investigators Dr. William Hellenbrand, M.D. Director of Catheterization Laboratory for Congenital Heart Disease and Ralph Mosca, M.D. Director of Pediatric Cardiac Surgery

• Miami Children's Hospital (Miami, FL) with investigators Evan Zahn, M.D. Chief, Cardiology and Redmond Burke, M.D. Chief Cardiovascular Surgery

"We are excited about the promise of bringing this new, non-surgical procedure to the thousands of U.S. patients suffering from congenital heart disease with defects that disrupt the blood flow from the right ventricle to the pulmonary artery," said Dr. James Lock, Cardiologist-in-Chief at Children's Hospital Boston. "Our first implant has been conducted with positive results — both clinically and from a quality of life perspective — for the patient by delaying the need for an invasive open heart procedure to restore valve function."

"Effective management of congenital heart defects over a patient's lifetime requires dedicated collaboration between cardiac surgeons and interventional cardiologists," added Dr. John Mayer, Senior Associate in Cardiac Surgery at Children's Hospital Boston. "Together, members of these two disciplines draw on a variety of treatment options and clinical pathways. We hope that the Melody valve will be an important addition to the choices available for our patients."

The defect often requires open heart surgery early in life to implant a prosthetic or bioprosthetic valved-conduit to establish adequate blood flow from the heart to the lungs. However, the functional life span of these conduits is relatively limited, and as a result, most patients with this type of defect may require multiple open heart surgeries to place new valved conduits as they grow over their lifetime.

To meet this clinical need, Medtronic says it will use this trial to evaluate the Melody valve and Ensemble delivery system as a catheter-based alternative treatment in order to restore effective pulmonary valve function and potentially prolong the functional life of the right ventricle to pulmonary artery conduits. This alternative treatment is aimed at reducing the number of open heart surgeries these patients must undergo.

To date, more than 200 patients have been treated with the therapy. The Melody valve and Ensemble system are not currently available in the U.S., but Medtronic has received Canadian approval and CE Mark approval in Europe for commercial sale of the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System.

For more information visit www.medtronic.com.

Related Content

Edwards LifeSciences Recalls Sapien 3 Certitude Delivery System
News | Heart Valve Technology| January 11, 2018
The U.S. Food and Drug Administration (FDA) announced that Edwards LifeSciences is recalling its Certitude Delivery...
Videos | Heart Valve Technology| January 04, 2018
Adam Greenbaum, M.D., co-director, Center for Structural Heart Disease, Henry Ford Hospital, Detroit, explains how hi
Edwards Acquires Harpoon Medical
News | Heart Valve Technology| December 07, 2017
December 7, 2017 — Edwards Lifesciences Corp.
Videos | Heart Valve Technology| November 15, 2017
Ted Feldman, M.D., MSCAI FACC FESC, director of the cardiac cath lab, Evanston Hospital, is the principal investigato
New Analyses Reinforce Hemodynamic Benefits of Evolut TAVR Platform in Intermediate-Risk Aortic Stenosis Patients
News | Heart Valve Technology| November 08, 2017
Medtronic plc recently presented new clinical research to support the positive clinical performance of the Evolut...
Videos | Heart Valve Technology| November 08, 2017
Philippe Genereux, M.D., co-director of the structural heart program at the Gagnon Cardiovascular Institute at Morris
Videos | Heart Valve Technology| November 08, 2017
Stephen Worthley, MB, BS, Ph.D., director of cardiac catheterization, University of Adelaide, Australia, presents the
Harpoon Mitral Valve Repair System data reported at TCT 2017
Feature | Heart Valve Technology| November 07, 2017
November 7, 2017 – A new study has found that a pioneering device to repair heart valves is safe and effective, and c
Videos | Heart Valve Technology| November 07, 2017
Ted Feldman, M.D., MSCAI FACC FESC, director of the cardiac cath lab, Evanston Hospital, explains the current state o
Overlay Init