Typically we refrain from posting on this blog the information that is easily available elsewhere. In view of us taking long position on BSX immediately after seven broker downgrades and the importance of this FDA decision, we are making an exception. Here is the reason for Boston Scientific going up after hours.
Today Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA) has unanimously recommended approval of an expanded indication for its cardiac resynchronization therapy defibrillators (CRT-Ds), including the COGNIS ® CRT-D. The panel recommended the expansion include the majority of the studied population of the landmark MADIT-CRT clinical trial, which evaluated the ability of these devices to slow the progression of heart failure in patients with asymptomatic or mild heart failure.
“Boston Scientific welcomes the panel’s decision to recommend expanding the current indication to include the majority of the MADIT-CRT population,” said Hank Kucheman, Executive Vice President and Group President, Cardiology, Rhythm and Vascular for Boston Scientific. “If an expanded indication is approved by the FDA, many additional heart failure patients would be eligible for this therapy, which has been clinically proved to slow the progression of this severe and life-limiting condition.”
If approved, Boston Scientific would become the only company with an FDA-approved CRT-D for high-risk New York Heart Association (NYHA) Class I and II(1) patients with Left Bundle Branch Block (LBBB) morphology and sinus rhythm. These 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.