The FDA cleared expanded indications for Medtronic‘s (NYSE:MDT) CoreValve TAVR devices, now cleared for use in patients with end-stage renal disease and those with low-grade, low-flow aortic stenosis.
Medtronic won approval from the FDA to modify the CoreValve’s labeling in November which included both its CoreValve and CoreValve Evolut R systems.
The changes to the labeling were approved based on Medtronic’s CoreValve U.S. expanded use study of high and very-high-risk subjects at need for aortic valve replacements, according to an email FierceMedicalDevices received from a Medtronic spokesperson.
Data from the study, which Medtronic released in October, examined patient populations with comorbidities including patients with end-stage renal disease and low gradient aortic stenosis.
In patients with end-stage renal disease, Medtronic said patients with the Corevalve exceeded the 30.3% all-cause mortality goals set out in its original CoreValve extreme risk study. Patients with end-stage renal failure also showed improved KCCQ scores of 27.5 points compared to baseline.
Findings from a study of patients with low gradient aortic stenosis reported being comparable with the CoreValve extreme risk study as well, Medtronic reported. Rates of all-cause mortality and major stroke were comparable between those who had low ejection fractions and normal ejection fractions, at 26.3% and 26% respectively. Patients also reported increased quality of life KCCQ scores, averaging 25-30% improvements.