Medtronic receives fda approval for "breakthrough" transcatheter pulmonary valve replacement for patients with congenital heart disease

Dublin, march 26, 2021 /prnewswire/ -- medtronic plc (nyse:mdt), the global leader in medical technology, today announced it has received u.s. food and drug administration (fda) approval for its harmony™ transcatheter pulmonary valve (tpv), the first minimally invasive therapy created to treat patients with a specific type of congenital heart defect of the right ventricle (rv), one of the four chambers of the heart, which makes it difficult for blood to travel from the heart to the lungs. the harmony tpv, which is placed inside a patient's native anatomy during a catheter-based procedure, was designated as a breakthrough therapy under fda's breakthrough device designation (bdd) program, an approval pathway intended to help patients receive more timely access to certain life-saving technologies.
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