Boston Scientific Corporation announces FDA approval of its INCEPTA, ENERGEN and PUNCTUA cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs) to treat heart failure and sudden cardiac death.
According to the company, the new devices offer enhanced therapy options, advanced battery longevity and a DF4 universal connector system in the industry’s smallest and thinnest platform.
The first implant of the company’s next-generation INCEPTA ICD occurred Tuesday, Nov. 29, at the University of Washington Medical Center in Seattle by Jeanne E. Poole, M.D., FHRS, FACC, Professor of Medicine and Director, Arrhythmia Service and Electrophysiology Laboratory.
The 4-SITE DF4 connector system reduces the volume of Boston Scientific’s single-chamber ICDs to 30.5cc and CRT-Ds to 32cc, while maintaining a thickness of less than 10mm.
The system is also designed to simplify and reduce the time needed for the implant procedure by combining three separate lead terminals into one integrated connection and leveraging the new EZ-4 Connector Tool which allows physicians to reduce the number of steps required during implant.
These next-generation devices also include options to promote appropriate therapy, reduce right ventricular pacing, and improve patient management through the availability of the LATITUDE Heart Failure Management weight scale and blood pressure cuff sensors.
Boston Scientific is a developer, manufacturer and marketer of medical devices.