In a significant development for congenital heart disease patients,
Medtronic, Inc. (NYSE: MDT), announced today that its Melody®
Transcatheter Pulmonary Valve has received U.S. Food and Drug
Administration (FDA) approval under a Humanitarian Device Exemption
(HDE). This innovative medical device is the first transcatheter heart
valve to receive FDA approval.
“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.”
Delivered through a catheter requiring only a small incision, the Melody
valve will benefit children and adults who are born with a malformation
of their pulmonary valve, which is the valve between the heart and
lungs. These patients often require open-heart surgery to restore
effective blood flow to their lungs. Previously, the only way to repair
or replace a failed pulmonary valve conduit was through additional
surgeries. To date, more than 1,100 patients worldwide have received a
Melody valve.
“The Melody Transcatheter Pulmonary Valve is a significant technological
breakthrough and offers a reprieve for many patients with congenital
heart disease – many of whom are young and will require several heart
surgeries over their lifetime,” said pediatric cardiologist Dr. William
E. Hellenbrand of the NewYork-Presbyterian Morgan Stanley Children’s
Hospital and Columbia University Medical Center.
“The Melody valve gives patients with congenital heart disease a new,
non-surgical approach to managing their disease.”
“This novel technology will improve the lives of thousands of patients
in the United States,” said Dr. John Liddicoat, vice president and
general manager of the Structural Heart division, part of the
CardioVascular business, at Medtronic. “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.”
In October 2006, the Melody valve became the first transcatheter valve
to receive regulatory approval anywhere in the world when it received
the CE (Conformité Européenne) mark. It is now approved by the FDA for
use in the United States under an HDE, a special regulatory approval for
treatments intended for fewer than 4,000 U.S. patients per year. HDEs
are granted for medical devices that have demonstrated reasonable safety
and probable benefit, but not clinical effectiveness.
Medtronic CardioVascular is committed to advancing the treatment of
coronary, peripheral, aortic and structural heart disease through
collaboration with leading clinicians, researchers and scientists
worldwide.