CardioExchange Archive

FDA Warns About High Dose Simvastatin– The FDA issued a drug safety communication today about an ongoing review of high dose simvastatin and increased risk of myopathy based on data from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial.FDA Panel Supports Expanded Indication for CRT-Ds– The FDA’s Circulatory System Devices Panel voted unanimously to support a broader indication for Boston Scientific CRT-D devices. The expanded indication, based on data from the MADIT-CRT trial, would include  NYHA Class I and II patients with LBBB, LVEF ≤ 30% and QRS duration ≥ 130ms. (Boston Scientific press release)FDA Delays Watchman Approval– The FDA has told Atritech Inc that it will have to perform another study to confirm the safety and efficacy of the Watchman Left Atrial Appendage Closure Technology before the device can gain market approval. (Atritech press release)