FDA approves revised labelling for Boston Scientific Defibrillators

The FDA has approved revised product labeling for the Boston Scientific Corporation Incepta, Energen, Punctua, Cognis and Teligen implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), to reflect increased longevity projections for these devices. The longevity projections are based on data submitted to the FDA and vary for each device dependent on the model type and settings. Projected device longevity exceeds 10 years for some models of Boston Scientific ICDs, and approaches eight years for its CRT-D devices, and nearly double that of comparable device models. The company backs these devices with warranties of up to 10 years in the US and some international markets.