Medtronic (NYSE:MDT) said today that the FDA will allow it to skip an advisory panel on high-risk patients for its CoreValve replacement heart valve, after data from a clinical study showed the transcatheter aortic heart implant is superior to open heart surgery.
"Upon reviewing the CoreValve trial’s results for high-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 press release.
The trial compared treatment with the CoreValve TAVI and open heart valve replacement surgery in 747 patients predicted to have a risk of operative mortality of 15% or higher at 30 days, Medtronic said. The study met its primary endpoint for all-cause mortality with a rate of 14.2%, compared with 19.1% for the control group.
Patients treated with the CoreValve device also showed low stroke rates in line with the control arm of the trial, with 3.9% of CoreValve subjects suffering a major stroke at 30 days compared with 3.1% for the control cohort. At 1 year, stroke rates were 5.8% for the CoreValve group and 7.0% for the control group.
Early TAVI models have been plagued by "paravalvular leakage," or blood flow around the implanted valve. Medtronic said the rates of PVL in the CoreValve group were "acceptably low" at 7.8% at discharge from the hospital and 6.1% after 1 year. The rate of permanent pacemaker implantation, another concern, was 19.8% at 1 month and, "importantly, for these patients a difference in mortality was not observed," the Minneapolis-based medical device company said.
"The extremely low mortality rates in both arms of the trial confirm that our heart teams were outstanding, particularly considering they had no prior experience with transcatheter aortic valve therapy," said co-principal investigator Dr. David Adams, of Mount Sinai Hospital in New York, in prepared remarks. "Our key finding that TAVR with CoreValve was associated with a significantly higher rate of survival at one year in patients at increased risk has significant and broad implications."
"The results of the CoreValve High Risk Study effectively demonstrate the value of the heart team approach, with an equal number of cardiac surgeons and interventionalists generating the compelling clinical outcomes," added Medtronic’s structural heart president Dr. John Liddicoat. "We applaud the investigators for their commitment to this rigorously designed study and for its meticulous execution. We also look forward to the potential impact these data will have on improving patient outcomes in real-world clinical practice once the CoreValve System receives FDA approval for patients at increased risk."