GAITHERSBURG, Maryland (Reuters) - Medtronic Inc won a U.S. advisory panel’s backing on Wednesday for a new type of heart valve that can be implanted without the open heart surgery required for traditional valves.
Advisers to the Food and Drug Administration unanimously recommended approval for the Melody heart valve for a limited group of people born with cardiac defects.
The vote makes it likely the FDA will approve the device as the agency usually follows panel recommendations.
The valve is designed for adults and children born with heart defects that impede blood flow from the right ventricle to the pulmonary artery. The device can be implanted by threading a tube through a leg vein to the heart.
Advisory panel members said the potential benefits outweighed concerns about fractures in a part of the device. They said patients should be monitored for complications and be told the device has a limited lifespan. Several said they hoped Medtronic would develop a more durable version in the future.
Dr. William Maisel, a cardiologist at Beth Israel Deaconess Medical Center in Boston, said “there is room for improvement for the device” but the company “demonstrated safety and probable benefit.”
The panel urged the FDA to require Medtronic to further study the valve’s performance after approval.
If the device wins agency approval, it could help Medtronic build a presence in the relatively new market for less-invasive valve replacement, known as transcatheter replacement.
Edwards Lifesciences Corp pioneered the technology for use in aortic valves, a larger market than the one Medtronic is targeting with Melody.
In February, Medtronic announced it was buying two privately held heart valve companies including CoreValve, a major player in transcatheter aortic valve technologies. Johnson & Johnson also is looking to compete in the area.
Panel chairman Jeffrey Borer, a cardiologist at Weill Cornell Medical College in New York, said the Melody device represented “a very important watershed event” with its less invasive system.
Medtronic said the Melody valve was intended for a small group of patients, many of them young, who previously underwent open-heart surgery and likely will need it repeated. Patients in the U.S. study ranged in age from 7 to 44 years old.
Use of the Melody device may delay or prevent future surgeries, potentially reducing the number of open-heart operations over a lifetime, the company said.
Current data “demonstrate the safety risks are acceptable” given the likely benefits, Dr. Tom Armitage, a Medtronic vice president, told the panel.
Medtronic is seeking approval under an exemption that allows use of a device in up to 4,000 patients per year if the maker demonstrates a probable benefit without unreasonable risk of harm. That is a lower standard of evidence than required for a traditional FDA approval.
The Melody valve met key goals in a Medtronic study of 99 U.S. patients that measured rates of successful implantation, death and serious complications, FDA reviewers said.
Agency staff said they felt fractures in the stent, a tiny mesh tube used to implant the valve, could be safely treated. The fractures raised concerns that pieces might break off and clog a blood vessel.
In Medtronic’s study, 18 percent of U.S. patients developed stent fractures and five of them needed repeat procedures. None developed a clot from the fractures.
The Melody valve already is approved in Europe and Canada.
Reporting by Lisa Richwine, editing by Bernard Orr