Transcatheter Device By Medtronic plc. Ordinary Shares (NYSE:MDT) Gets FDA Nod

The Melody Transcatheter Pulmonary Valve that has been developed by Medtronic plc. Ordinary Shares (NYSE:MDT) has been approved by the U.S. Food and Drug Administration. The device is implanted in patients in cases where surgical pulmonary heart valves are not working. This transcatheter pulmonary valve is the first of its kind to be approved in the United States.

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“Melody TPV is uniquely designed for use in the pulmonic position and is thus well suited for implantation in failed surgical pulmonary heart valves. This approval further demonstrates our commitment to improving treatment options for congenital heart disease…,” Rhonda Robb, a general manager and vice president at a Medtronic subsidiary said.

Open-heart surgery

In cases where a surgical valve has degenerated over the course of time, a replacement is normally required and this usually involves open-heart surgery. But with the Melody Transcatheter Pulmonary Valve, patients now have an option that is minimally invasive. In the course of the procedure to place the Melody TPV inside the surgical pulmonary valve that is failing, a delivery catheter which has been designed specifically for this purpose is utilized.

As the pioneering transcatheter heart valve in the world, this device has been implanted in patients numbering more than 10,000 across the globe. This device first got the CE Mark more than a decade ago during which time numerous trials have proven the efficacy of the device in delaying open heart surgery with a view to replacing the broken pulmonary heart valve. It was first launched in the United States in 2010 after getting the approval of the Food and Drug Administration.

Global reach

With the transcatheter valve market expected to be worth $8.62 billion globally, Medtronic is well placed to take advantage. Besides the Melody TPV, Medtronic has a wide range of devices and technologies that are used in treating cardiac arrhythmias and cardiovascular diseases. The Dublin, Ireland-based medical technology firm is among the largest in the world in its space. It has a presence in over 160 countries and employs over 88,000 people across the globe.

In Thursday’s trading session, shares of Medtronic plc fell by 1.76% to close the day at $81.83 a share.

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