NATICK, Mass., Sept. 16 /PRNewswire-FirstCall / -- Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for its cardiac resynchronization therapy defibrillators (CRT-Ds), including the COGNIS® CRT-D. The exclusive expanded indication is effective immediately and makes Boston Scientific CRT-Ds the only devices approved by the FDA for patients in all New York Heart Association (NYHA) classes of heart failure(1).
The Company's CRT-Ds had previously been approved for NYHA Class III and IV patients. The expanded indication approves Boston Scientific CRT-Ds for use in high risk(2) NYHA Class I and II patients with Left Bundle Branch Block(3) (LBBB). These patients accounted for 70 percent of the MADIT-CRT clinical trial population.
"The MADIT-CRT trial demonstrated that Boston Scientific's CRT-Ds reduce death and heart failure events, even for patients without symptoms," said Kenneth Stein, M.D., Senior Vice President and Chief Medical Officer, CRM, for Boston Scientific's Cardiology, Rhythm and Vascular Group. "Preventing or delaying a first heart failure event in NYHA Class I and II patients with LBBB is critical because these patients are eight times more likely to have a recurring event after their initial event."
In response to a request from the FDA, Boston Scientific worked with the MADIT-CRT Executive Committee to perform further analysis of the trial data to determine if there were additional criteria to identify patients at risk for heart failure. The Company's analysis showed that LBBB was the best baseline characteristic to differentiate which Class I and II patients would be most likely to benefit from a CRT-D. MADIT-CRT data demonstrated that patients with LBBB who received CRT-D therapy showed a relative risk reduction of all-cause mortality or first heart failure event of 57 percent when compared to those who received implantable cardioverter defibrillator therapy (p<0.001).
"We are extremely pleased with the FDA's decision to expand the indication for Boston Scientific CRT-Ds, which substantially broadens the population of heart failure patients who can benefit from this therapy," said Hank Kucheman, Executive Vice President and Group President, Cardiology, Rhythm and Vascular for Boston Scientific. "The addition of LBBB to the indication provides a strong, objective identifier of patients eligible for a CRT-D, meeting the needs of both implanting and referring physicians."
MADIT-CRT is the world's largest randomized CRT-D study of NYHA Class I and II patients, with more than 1,800 patients enrolled at 110 centers worldwide.
For a copy of the technical reference guide, which includes important information for use in the indicated patient population, call 1.800.CARDIAC (227.3422) or 1.866.484.3268.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com .
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(1) The NYHA clinical classifications of heart failure rank patients as Class I-II-III-IV, according to the degree of symptoms or functional limits, from asymptomatic to bed ridden.
(2) High-risk is defined as QRS width greater than or equal to 130 milliseconds and Left Ventricular Ejection Fraction less than or equal to 30 percent. MADIT-CRT patients are asymptomatic or mildly symptomatic, NYHA Class I (ischemic) and Class II (ischemic and non-ischemic).
(3) LBBB is a condition in which the activation of the left ventricle is delayed. As a result, portions of the left ventricle contract later than the rest of the left ventricle and right ventricle, reducing the heart's pumping ability. The intent of cardiac resynchronization therapy is to restore synchronous contraction of the ventricles.