FDA regulators were so pleased with new clinical trial results from a U.S. pivotal study of Medtronic’s (NYSE:MDT) CoreValve transcatheter aortic valve implantation system that the agency is letting the device skip a step on its way to the U.S. market, Medtronic announced today.
"Upon reviewing the CoreValve Trial’s results for extreme risk patients, the FDA has determined it has sufficient information to evaluate the safety and efficacy of the Medtronic CoreValve System for this patient group without the need for an external expert panel," according to a company statement.
That means that CoreValve may hit the U.S. market before summer 2014.
The company today released highly anticipated results from its U.S. CoreValve pivotal trial, presenting before a packed crowed at this year’s Transcatheter Cardiovascular Therapeutics symposium in San Francisco.
The company reported low rates of major stroke and all-cause mortality at 1 month and at 1 year following implantation, with nearly 75% of patient participants alive and stroke-free at 12 months, said co-principal investigator Dr. Jeffrey Popma.
Researchers posted 1-month and 1-year stroke rates that were among the lowest reported for a TAVI system, reported at 2.4% and 4.1% respectively. Strokes rates were even lower among the approximately 800 additional patients enrolled in the continuing access arm of the trial, with a 1.8% major stroke rate at 1 month.
Rates of paravalvular leakage were also encouraging, with outcomes actually improving over time. About 11.5% of patients were reported with leakage at 1 month, improving to 4.1% at 1 year, an outcome that surprised other members of the morning’s panel. Dr. Popma explained that the decreasing leakage may have to do with the valve size selected for the patients and the positioning of the valves in the heart.