FDA Approves Medtronic Melody TPV For Implantation in Failed Pulmonary Heart Valves

Medtronic recently announced that its Melody® Transcatheter Pulmonary Valve (TPV) is the first transcatheter pulmonary valve to receive FDA approval for implantation in patients with failed surgical bioprosthetic pulmonary heart valves. Medtronic touts the Melody TPV as providing these patients with a minimally invasive treatment option as an alternative to additional open-heart surgery.

The Melody TPV was previously approved under the FDA’s Humanitarian Device Exemption (HDE), a program for technologies that may treat fewer than 4,000 patients a year, subject to additional regulations, without meeting all of the traditional pre-market approval rules.

Commenting on the approval, Dr. Jeremy Asnes of the Yale School of Medicine said:

As the 1st commercially available transcatheter heart valve, the Melody TPV brought a breakthrough non-surgical option to treat failing pulmonary valve conduits. Thousands of congenital patients globally have benefited from this therapy in the past decade. With this expanded indication, we can further reduce the need for obtrusive open-heart surgery and allow even more patients to benefit from this minimally invasive treatment option.

Grand View Research predicts that the global transcatheter valve market is expected to reach a worth of $8.62 billion by 2024. According to the Centers for Disease Control and Prevention, congenital heart defects are the most common birth defect in America and the top killer of infants with birth defects. An estimated 40,000 babies are born with congenital heart defects in the United States every year.

David Kim
David T. Kim practices intellectual property law, with a focus on patent prosecution and counseling in electronic and software technologies. Prior to joining the firm, he has worked at General Electric for five years as an embedded systems software engineer. In his engineering role, he designed and programmed inter-device communications, device drivers, interfaces, complex signal processing filters, and more contributing on both the hardware and software fronts. He helped GE launch numerous high-profile and successful products. During law school, David was a member of BU-MIT Entrepreneurship and IP Clinic and assisted student entrepreneurs in obtaining IP protections and counseling about legal ramifications of their business decisions.
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