BSX: Positive Results from MADIT Trial

Boston Scientific Corporation (BSX) announced positive final results from its landmark MADIT-CRT trial. The MADIT trial was conducted to evaluate the effectiveness of the company’s cardiac resynchronization therapy defibrillators (CRT-Ds), compared to the traditional implantable cardioverter defibrillators (ICDs).

MADIT-CRT is the world’s largest randomized NYHA Class I/II CRT-D trial, engulfing more than 1,800 asymptomatic or mildly symptomatic patients across 110 centers in 14 countries.

It is estimated that roughly 22 million people in the world suffer from some form of heart failure, with more than 5.5 million of them being Americans. Class I or II accounted for approximately 70% of all heart failure patients in the U.S. Patients are classified as Class I-II-III-IV by the New York Heart Association based on the degree of symptoms or functional limits, from asymptomatic to bed ridden.

Major findings in the study were as follows:

• The primary endpoint demonstrated that Boston Scientific’s CRT-Ds resulted in a 34% reduction in the risk of first heart failure in asymptomatic and mild (NYHA Class I and II) heart failure patients, compared to standard ICDs.
• CRT-D therapy reduced the risk of heart failure by 41% compared to ICDs.
• CRT-Ds provided substantial improvements in Left Ventricular Ejection Fraction (LVEF), a measurement of how well the heart is pumping. Patients treated with CRT-Ds demonstrated an 11% improvement in LVEF after a year, compared to a 3% improvement in ICDs.

We think that the positive test results will boost demand for BSX’s CRT-Ds, which will essentially drive the company’s top-line. Boston Scientific reported fiscal second quarter results with the cardiac rhythm management {CRM} segment, registering revenue growth of 5% year over year. Within the CRM segment, ICD sales increased roughly 8% year over year to $454 million in the quarter.

Boston Scientific is a manufacturer of medical devices and products used in a broad range of interventional medical specialties. The company faces significant competition across its product portfolio. The primary competitors include Johnson & Johnson (JNJ), Medtronic Inc. (MDT), Abbott Laboratories (ABT) and St. Jude Medical Inc. (STJ). Based on the company’s performance, we have assigned a Neutral recommendation on the stock.

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