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


February 23, 2007

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