Minute Insight: Medtronic Relaunches Harmony Pulmonary Valve Replacement
The company pulled Harmony from the market about a year ago following six reports of the capsule at the end of its delivery catheter breaking.
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Medtech Insight's Cardiovascular Catch-Up highlights recent news on cardiovascular devices and innovations that you may have missed. This edition covers the two-year results of an 86-patient study of Medtronic’s Harmony transcatheter pulmonary valve.
The US FDA gave its highest risk classification to a recall of Medtronic’s Harmony Delivery Catheter. This is the second high-profile recall action that the device giant has racked up this year related to catheters.
The Harmony transcatheter pulmonary valve can be used to improve blood flow to the lungs in patients with severe pulmonary valve regurgitation as a result of a congenital malformation of the right ventricular outflow tract.