FDA Advisory Panel Recommends Expanded Indication for Heart Failure Devices
Boston Scientific Corporation has announced that the Circulatory System Devices Panel of the 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."