FDA Grants HDE Approval for Medtronic's Melody Transcatheter Heart Valve

January 25, 2010—Medtronic, Inc. (Minneapolis, MN) announced that its Melody transcatheter pulmonary valve has received US Food and Drug Administration (FDA) approval under a humanitarian device exemption (HDE). The company noted that HDE approval is for treatments intended for fewer than 4,000 patients per year in the United States. HDEs are granted for medical devices that have demonstrated reasonable safety and probable benefit, but not clinical effectiveness. The Melody valve received CE Mark approval in October 2006.

The transcatheter Melody valve is intended to treat children and adults with congenital malformation of the pulmonary valve. To date, more than 1,100 patients worldwide have received a Melody valve, Medtronic stated.

According to a statement from the FDA, the Medtronic Melody transcatheter pulmonary valve and ensemble delivery system is the first heart valve to be implanted through a catheter. The agency noted that this new approach to treating adults and children with previously implanted, yet poorly functioning pulmonary valve conduits can delay the need for open heart surgery. Conduits can have a limited lifespan and often require replacement. The Melody is intended to provide another option to conduit replacement. Approval of the Melody valve should be especially beneficial to pediatric patients with right-sided valvular heart disease who may face several surgeries over their lifetimes, the FDA stated.

"The FDA's approval of Melody allows patients to undergo a much less invasive procedure to treat their heart condition," commented Jeffrey Shuren, MD, Director of the FDA's Center for Devices and Radiological Health. "Congenital heart defects represent the number one birth defect worldwide, and this approval represents a new, first-of-a-kind treatment option for some of those patients."

As a condition of the FDA's approval, Medtronic will conduct two postapproval studies to assess long-term risks and benefits, as well as to evaluate generalizability, which is the physician specialization needed to perform the implantation procedure. One study will continue to follow 150 participants from the initial clinical trial for 5 years, and the second study will enroll more than 100 new participants to be evaluated for 5 years to assess the training program. Safety and benefit assessments will be part of both studies. The FDA also requires that Medtronic maintain a database of Melody recipients.

The FDA stated that manufacturers of most HDE devices are prohibited from selling their device for an amount that exceeds the costs of research and development, fabrication, and distribution of the device. However, under a provision in the Pediatric Medical Device Safety and Improvement Act of 2007, this prohibition does not apply for an agency-specified number of Melody devices sold each year that are intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients.