Melody Pulmonary Valve
As an alternative to open heart surgery, Medtronic has sought and won approval from the FDA over its minimally invasive replacement heart valve.
Rather than open-heart surgery, the Melody transcatheter pulmonary valve and delivery system can be implanted via a catheter.
The FDA approved the device Monday under its humanitarian device exemption policy, reports Reuters. That allows a medical device to proceed even though it is used to treat fewer than 4,000 U.S. patients a year, avoiding the normal pre-market approval rules.
The approval is for limited use as long as the health benefits outweigh the risk of injury or illness and the device can only be used at medical institutions with an overseeing Institutional Review Board.
The Melody wave is implanted via a catheter or tube in a leg vein and guided up to the heart. This procedure is used when patients have poorly functioning already implanted pulmonary valve conduits, which are used to treat congenital heart defects of the pulmonary valve.
The EU approved the new heart valve in 2006.
Congenital heart defects are a top killer of infants with birth defects, according to the American Heart Association. An estimated 36,000 babies are born with CHD every year.
An article published in the Journal of the American Medical Association last month reports that FDA approval of cardiovascular devices is often based on weak studies that are prone to bias. Researchers reviewed 123 FDA summaries of studies for 78 applications for devices such as pacemakers, stents, and heart-valve replacements. 65 percent were supported by a single study.
Public Citizen has criticized the FDA program that fast-tracks approval of certain medical devices.
"It would be helpful to have stronger legislation because the standards for approval of devices are not as stringent as approval for drugs as pointed out in this paper," said Sidney Wolfe, director of the consumer advocacy group Public Citizen.
The melody valve underwent a clinical study of 99 participants in the U.S. and 68 iin Europe with the majority of participants having noted improvements in their clinical symptoms, according to the FDA.
As a condition of approval, Medtronic Inc. of Minneapolis must conduct two post-approval studies to assess long-term risks and benefits.
Medtronic Inc. has had several medical devices recalled. The Sprint Fidelis Defibrillator Leads were recalled due to a small number of fractures causing inappropriate shocks. In April 2004, Medtronic recalled two models of defibrillators after reports the devices did not charge properly.
It was the Riegel v Medtronic case before the U.S. Supreme Court that determined medical device makers are shielded from injured plaintiff lawsuits under state products liability law. Donna Riegel brought suit against Medtronic after the company’s catheter ruptured in Charles Riegel’s coronary artery during heart surgery.
The Medical Device Safety Act would restore consumer protections eliminated by Riegel v. Medtronic. #