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FDA OKs Expanded Patient Population for CoreValve
Patients with End-Stage Renal Disease and Low Flow, Low Gradient AS Now Included
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CoreValve (artist rendition)
Medtronic CoreValve
February 3, 2016 (updated February 4) -- Medtronic plc (NYSE:MDT) announced today that the FDA has revised the IFU (Instructions for Use) labeling for the CoreValve System to now include patients with end-stage renal disease and low flow, low gradient aortic stenosis.

Previously, physicians were cautioned in the IFU against treating these patient populations with TAVR because of their severe comorbidities. The FDA's decision was based on positive data from the CoreValve U.S. Expanded Use Study presented at the TCT meeting last October, which showed impressive rates of stroke and excellent survival in these patients at one-year.

The Expanded Use Study identified three major patient populations that could benefit from TAVR with the CoreValve. The first, valve-in-valve procedures, was approved by the FDA in March 2015. The remaining two, end-stage renal disease and low gradient aortic stenosis, were added today. You can download the complete revised IFU here (Section 11.3 contains the newly revised indications).

Those patients with low flow, low gradient showed one-year mortality rates of 23.1% and major stroke of 4.9%. For those with end-stage renal disease, one-year mortality was 32.7% and major stroke was only 1%. Both patient populations showed significantly improved quality of life at one-year follow-up (P < 0.001 from baseline). Results from both cohorts are comparable to those seen in the CoreValve U.S. Pivotal Extreme Risk Trial.

Reported by Burt Cohen, February 3, 2016, updated February 4 with IFU and valve-in-valve information