The FDA approved the CoreValve device for transcatheter aortic valve replacement (TAVR) in high-risk patients with severe aortic stenosis without a review from an expert panel. While the favorable decision was expected, the road to it developed a few potholes.
The decision process mirrors the agency’s earlier approval for CoreValve for extremely high-risk patients In January of this year, Medtronic won the FDA’s blessing for CoreValve as a treatment for extreme risk patients after results for the pivotal trial were unveiled Oct. 29 at the Transcatheter Cardiovascular Therapeutics scientific session in San Francisco. At the time, the FDA announced that it had decided to not convene an expert panel.
Researchers presented findings in March from the U.S. CoreValve High Risk study at the American College of Cardiology’s 2014 late-breaking clinical trials session in Washington, D.C. The trial assessed the safety and efficacy of CoreValve in patients with severe aortic stenosis who have a 15 percent or higher risk of death within 30 days of surgery, as determined by a heart team. The primary endpoint was the death rate at one year. The secondary clinical endpoint was major adverse cardiovascular and cerebrovascular events at 30 days and one year.
Forty-five centers enrolled almost 750 patients randomized to TAVR treatment or surgical aortic valve replacement between February 2011 and September 2012. At one year, high-risk patients treated with CoreValve had a mortality rate of 14.2 percent compared with 19.1 percent for the surgical group.
The FDA’s approval covers the full CoreValve platform, which includes 23mm, 26mm, 29mm and 31mm size valves delivered through an 18Fr system.
While clinical results have been positive, Medtronic has faced significant troubles with CoreValve in the legal arena. Earlier this year, a federal judge imposed a temporary injunction limiting sale of the device in a patent infringement challenge from rival Edwards LifeSciences. Edwards and Medtronic produce the only TAVR devices approved for marketing in the U.S.
The companies reached an agreement in May that requires Medtronic to pay a one-time fee of $750 million to Edwards. Medtronic also will make royalty payments to Edwards for several years.