FDA approves first percutaneous heart valve, Medtronic’s Melody Pulmonary Valve

The FDA today approved the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System. It is the first percutaneous valve to receive FDA approval. The Melody valve is intended to help patients with poorly functioning pulmonary valve conduits delay the need for open-heart surgery.

The device was approved for use under the FDA’s Humanitarian Device Exemption (HDE) program. Use of the valve will therefore only be used at hospitals that have an Institutional Review Board. In October 2006, the valve received the CE mark in Europe, becoming the the first transcatheter valve to receive regulatory approval anywhere in the world.

“The FDA’s approval of Melody allows patients to undergo a much less invasive procedure to treat their heart condition,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in an FDA press release. “Congenital heart defects represent the number one birth defect worldwide and this approval represents a new, first-of-a-kind treatment option for some of those patients.”

As a condition of approval the FDA is requiring Medtronic to perform two post-approval studies “to assess long-term risks and benefits as well as to evaluate the physician specialization needed to perform the implantation procedure, also called generalizability.”

Here is the FDA press release:

FDA Approves First Percutaneous Heart Valve

The U.S. Food and Drug Administration today approved the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, the first heart valve to be implanted through a catheter, or tube, in a leg vein and guided up to the heart. This new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits can delay the need for open-heart surgery.

Conduits are surgically implanted valves used to treat congenital heart defects of the pulmonary valve. Patients with congenital heart defects have narrowed, leaky, or missing pulmonary valves that impede the proper flow of blood from the heart’s right ventricle to the pulmonary artery, which then sends the blood on to the lungs for oxygenation. Conduits can have a limited lifespan and often require replacement. The Melody is intended to provide another option to conduit replacement.

“The FDA’s approval of Melody allows patients to undergo a much less invasive procedure to treat their heart condition,” said Jeffrey Shuren, J.D., M.D., director of the FDA’s Center for Devices and Radiological Health. “Congenital heart defects represent the number one birth defect worldwide and this approval represents a new, first-of-a-kind treatment option for some of those patients.”

Like other valves, the Melody does not cure the heart condition and over time, the Melody may wear and require replacement. However, it is implanted without open heart surgery, can prop open the poorly functioning conduit, and can keep blood flowing in the proper direction because of the tissue valve in the Melody. These characteristics will allow a patient’s conduit to function longer than usual, which can delay the need for more invasive open-heart surgery.

Approval of the Melody valve should be especially beneficial to pediatric patients with right-sided valvular heart disease who may face several surgeries over their lifetimes.

Clinical studies of 99 participants in the United States and 68 participants in Europe showed that the device improved function of the heart, and the majority of participants have noted improvements in their clinical symptoms. The device showed similar, limited durability compared with existing alternative treatments; 21 percent of U.S. participants experienced a stent fracture, a rate consistent with stent fractures reported for the bare metal stents presently used to treat congenital heart defects of the pulmonary valve.

As a condition of the FDA’s approval, the system’s manufacturer, Medtronic Inc. of Minneapolis, will conduct two post-approval studies to assess long-term risks and benefits as well as to evaluate the physician specialization needed to perform the implantation procedure, also called generalizability. One study will continue to follow 150 participants from the initial clinical trial for five years, and the second study will enroll more than 100 new participants to be evaluated over five years, in order to evaluate and assess the training program. Safety and benefit assessments will be part of both studies. The FDA also requires that Medtronic maintain a database of Melody recipients.

The FDA approved the Melody under the Humanitarian Device Exemption (HDE) program, which supports the development of medical devices intended to benefit patients in the treatment or diagnosis of diseases or conditions affecting fewer than 4,000 people in the United States per year. Under an HDE, the FDA can approve a device for limited use if there is a reasonable assurance that the device is safe and if the probable benefit to health outweighs the risk of injury or illness. Such products can only be used at medical institutions with an overseeing Institutional Review Board.

Manufacturers of most HDE devices are prohibited from selling their device for an amount that exceeds the costs of research and development, fabrication and distribution of the device. However, this prohibition does not apply to an agency-specified number of Melody devices sold each year and intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients, due to a provision in the Pediatric medical Device Safety and Improvement Act of 2007.

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Here is the Medtronic press release:

Medtronic Receives FDA Approval for First Replacement Heart Valve Implanted Without Surgery
Melody® Transcatheter Pulmonary Valve Offers Non-Surgical Valve Replacement Option for Congenital Heart Disease Patients

MINNEAPOLIS – Jan. 25, 2009 – 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.

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.

ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 24, 2009. Actual results may differ materially from anticipated results.

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