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www.fdanews.com/articles/159470-advisory-panel-splits-over-expanded-indications-for-medtronics-crt-line

Advisory Panel Splits Over Expanded Indications for Medtronic’s CRT Line

October 17, 2013
A divided Circulatory System Devices Panel grappled with fine distinctions in risk-benefit tradeoffs before voting to expand use of two Medtronic heart failure products to treat patients with atrial ventricular block and reduced heart function. The question on the table Tuesday was whether Medtronic’s Cardiac Resynchronization Therapy-Pacemaker (CRT-P) and Cardiac Resynchronization Therapy-Defibrillator (CRT-D) should be indicated for use in patients.
Devices & Diagnostics Letter