FDA Approval Awarded to Medtronic Inc. Heart Valve
FDA

On Monday, as has been confirmed by official announcements, the US Food and Drug Administration awarded its approval to Medtronic Inc.'s heart valve, a breakthrough new device that can be implanted without an open-heart surgery.

Christened the transcatheter pulmonary valve, the new offering has been designed in a way which allows it to be implanted through a tiny catheter which is inserted into a patient's body. It works by replacing the pulmonary valve in patients who are born with a defect of the heart.

Melody has become the first ever device which can be implanted without a surgery to gain approval for marketing across America.

"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. However, it is noteworthy that the new device itself does not treat the heart problem and patients fitted with the valve would most likely have to replace it after sometime.

Melody was awarded approval under the FDA's Humanitarian Device Exemption program, which allows easy approval of products that help treat a condition or disease that is currently affecting 4,000 or fewer American patients every year.

 

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