FDA OKs Expanded Patient Population for CoreValve

The FDA has revised the instructions for use labeling for the Medtronic’s CoreValve System to include patients with end-stage renal disease and low flow, low gradient aortic stenosis, the company has announced.

Previously, physicians were advised not to treat this patient population with transcatheter aortic valve replacement due to severe comorbidities.

The decision was based on positive CoreValve data on stroke rates and survival in these patients at one year. — Jonathon Shacat