Medtronic Receives FDA Approval to Treat Mildly Symptomatic Heart Failure Patients Through Expanded Indication for CRT-D
Medtronic, Inc. announces the U.S. Food and Drug Administration (FDA) approved an expanded indication for its cardiac resynchronization therapy with implantable cardioverter defibrillator (CRT-D) devices. With approval, this advanced therapy can now be used earlier, in a mildly symptomatic heart failure patient population, potentially improving survival, reducing hospitalizations, and preventing disease progression. The expanded indication includes New York Heart Association (NYHA) Class II heart failure patients with a left ventricular ejection fraction (LVEF) of less than or equal to 30 percent, left bundle branch block (LBBB), and a QRS duration greater than or equal to 130 milliseconds. Nearly 200,000 Americans are considered NYHA Class II, with another 620,000 people worldwide fitting this designation. Medtronic CRT-D devices were previously indicated to treat certain patients with moderate-to-severe heart failure (NYHA Class III and IV), and have safely and effectively been used in these patients for more than a decade. Learn more at http://bit.ly/HBU32N.