Medtronic’s Melody Gets FDA Approval For Pulmonary Valve Replacement
In case you missed it, there was a very interesting announcement yesterday about Medtronic’s minimally invasive heart valve replacement, known as the Melody heart valve. Here are the highlights…
U.S. regulators have approved Medtronic Inc’s minimally invasive heart valve, one of the first replacement valves that can be implanted via a catheter rather than open-heart surgery.
Medtronic’s Melody Heart Valve Replacement
The Food and Drug Administration (FDA) approved Medtronic’s Melody transcatheter pulmonary valve and delivery system under its humanitarian device exemption policy. The exemption policy allows the development of a medical device to treat a condition affecting fewer than 4,000 U.S. patients per year.
Under the policy, a device is approved for limited use on the assurance that its health benefits outweigh the risk of injury or illness.
The device “allows patients to undergo a much less-invasive procedure to treat their heart condition,” said Jeffrey Shuren, director of the FDA’s devices division. The valve doesn’t cure the heart condition, however, and over time it will likely need to be replaced.
The Melody valve is implanted through a catheter, or tube, in a leg vein and guided up to the heart without trauma to the patient’s sternum or ribs. Medtronic’s delivery system is known as the Ensemble Transcatheter Delivery System (shown below). The approach is intended to treat patients with previously implanted but poorly functioning pulmonary valves.
The Ensemble Transcatheter Delivery System
Conduits are surgically implanted valves used to treat congenital heart defects in the pulmonary valve. Patients with such defects have narrowed (stenosis) or leaky (regurgitation) pulmonary valves that impede blood flow from the heart’s right ventricle to the pulmonary artery that carries blood to the lungs.
The FDA approval is viewed as another step in the right direction for Medtronic, and other heart valve manufacturers, like Edwards Lifesciences, that are looking to achieve FDA approval for transcatheter solutions that address valvular defects impacting the pulmonary valve and the aortic valve. Other companies, including Abbot Laboratories with its MitraClip technology, are also in FDA trials for catheter-based solutions that repair defects in the mitral valve, specifically mitral regurgitation.
Needless to say, this continues to be an exciting time for the development of minimally invasive technology for heart valve replacement and heart valve repair.
Keep on tickin!
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About The Author: Adam Pick is a double, heart valve surgery patient and author of The Patient’s Guide To Heart Valve Surgery. This unique book integrates the clinical facts of heart valve surgery with the personal experiences of 135 former valve surgery patients to help patients and caregivers better understand the problems, the opportunities and the realities of heart valve surgery. To learn more about Adam and his heart valve surgery book, click here.
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January 26th, 2010 at 3:03 pm
Wow, Adam. Does this mean someone that needs an aortic valve replacement would be eligible for this type of “installation?” Peter is doing ok so far…you may not remember, but he was the one with the high pottasium after trying to take supplements to “dissolve” the scarring in his aortic valve. Thanks. Galina