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FDA clears Boston Scientific CRT-Ds expanded indication

Boston Scientific has received the US Food and Drug Administration (FDA) approval for an expanded indication of its cardiac resynchronization therapy defibrillators (CRT-Ds), for treating patients in all New York Heart Association (NYHA) classes of heart failure.

The CRT-Ds had previously been approved for NYHA Class III and IV patients and the current expanded indication approves for use in high risk NYHA Class I and II patients with Left Bundle Branch Block (LBBB), who account for 70% of the Madit-CRT clinical trial population.

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.

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% when compared to those who received implantable cardioverter defibrillator therapy.

Boston Scientific Cardiology Rhythm and Vascular executive vice president and group president Hank Kucheman said that they 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.

“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,” Kucheman said.