Boston Scientific Receives FDA Clearance for New ICDs, CRT-Ds


December 6, 2011

The Incepta, Energen and Punctua cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs) from Boston Scientific are indicated to treat heart failure and sudden cardiac death. 

They offer enhanced therapy options, advanced battery longevity and a DF4 universal connector system in a small, thin platform. The connector system reduces the volume of the company’s single-chamber ICDs to 30.5cc and CRT-Ds to 32cc, while maintaining a thickness of less than 10mm. The 4-SITE system is also designed to simplify and reduce the time needed for the implant procedure; it accomplishes this by combining three separate lead terminals into one integrated connection and leveraging the new EZ-4 Connector Tool. This allows physicians to reduce the number of steps required during implant.

Each of the new devices also features options to integrate with the Latitude Heart Failure Management weight scale and blood pressure cuff sensors. In this way they can promote appropriate therapy, reduce right ventricular pacing and improve patient management. 

All three devices received U.S. Food and Drug Administration (FDA) approval in November 2011.

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