September 17th, 2010
FDA Grants Expanded Indication to CRT-D Devices
The FDA has expanded the indication for CRT-D devices made by Boston Scientific. Previously, the devices had been approved only in NYHA Class III and IV patients. The expanded indication now includes Class I and II patients who have left bundle branch block. The expanded indication is based on data from the MADIT-CRT trial.
“This approval allows heart failure patients with left bundle branch block to benefit from this therapy,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in an FDA press release. “The FDA is pleased to safely make this new technology available for a greater number of heart failure patients.”