FDA approves three new Boston Sci CRT-Ds/ICDs

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Physicians now have three more options for cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs) after the FDA approved Boston Scientific’s Incepta, Energen and Punctua devices to treat both heart failure and sudden cardiac death.

Natick, Mass.-based Boston Scientific said that the devices will enhance therapy with battery longevity and a four-site DF4 universal connector system, which is built on the company’s Reliance platform of defibrillation leads.

The connector system reduces the volume of single-chamber ICDs to 30.5 ccs and CRT-Ds to 32ccs, while maintaining a thickness of less than 10mm.

Boston Scientific said that it will provide extended warranties for the newly approved devices in the U.S. and other countries for up to 10 years (depending on the model).