CRT-D for heart failure crosses major hurdle toward FDA approval

The FDA’s Circulatory System Devices Panel has unanimously recommended approval of an expanded indication for cardiac resynchronization therapy defibrillators (CRT-Ds), including Boston Scientific's Cognis CRT-D.

The panel recommended the expansion include the majority of the studied population of the MADIT-CRT clinical trial, sponsored by Boston Scientific, which evaluated the ability of these devices to slow the progression of heart failure in patients with asymptomatic or mild heart failure. Results of the MADIT-CRT trial, led by Arthur Moss, MD, from the University of Rochester Medical Center, were published in the October 2009 issue of the New England Journal of Medicine.

If approved, the Natick, Mass.-based Boston Scientific said it would become the only company with an FDA-approved CRT-D for high-risk N.Y. Heart Association (NYHA) Class I and II patients with left-bundle branch block morphology and sinus rhythm. The patients accounted for 70 percent of the MADIT-CRT population.

Currently, heart failure patients must be defined as NYHA Class III or IV to be indicated for a CRT-D device.