Medtronic's Melody percutaneous pulmonary heart valve is the first transcatheter heart valve available in the U.S. following FDA humanitarian device exemption approval, announced Jan. 25.

The device is an important technology breakthrough and is clinically significant for some with congenital heart defects, though it addresses a small population.

The valve is a stopgap to allow the approximately 1,000 adults and children per year in the U.S. who experience failure of a previously repaired right ventricular outflow tract to delay their next open heart surgery (¹ Also see "Medtronic Plans To Launch Melody Valve In The U.S. By April 2010" - Medtech Insight, 31 August, 2009.).

Congenital heart defects of the pulmonary valve are treated with valve conduits that have a limited lifespan. Patients often require open-heart surgery, perhaps multiple times, to repair the conduit.

"The FDA's approval of Melody allows patients to undergo a much less invasive procedure to treat their heart condition," said Jeffrey Shuren, director of CDRH.

As a condition of approval, Medtronic is required to perform two post-market studies: one following 150 participants from the pre-market trial for five years and the other enrolling more than 100 new participants for five-year follow-up.

An HDE, based on proof of safety and probable effectiveness, limits annual sales of a device to 4,000 U.S. patients per year.

It also typically restricts a manufacturer from pricing the device for greater than the per-item cost of R&D, fabrication and distribution. However, FDA says this profit restriction will not apply to an "agency-specified number" of Melody valves intended for use in pediatric patients due to provisions in the 2007 FDA Amendments Act aimed at encouraging pediatric device development (² Also see "Guidance: How To Profit From Humanitarian-Use Devices In Pediatric Patients" - Medtech Insight, 11 August, 2008.).

Medtronic and Edwards Lifesciences are both pursuing U.S. approval for aortic transcatheter valves, which would service a much larger and more profitable market (³ Also see "Medtronic Catapults Into Transcatheter Valve Market With Billion-Dollar Buys" - Medtech Insight, 2 March, 2009.).

- David Filmore ( ⁴ d.filmore@elsevier.com )

FDA OKs Medtronic's Melody HDE In First Transcatheter Valve Approval

More from Archive

More from Medtech Insight