Boston Scientific has received CE approval for three cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs), called INCEPTA, ENERGEN and PUNCTUA. They are approved for treating heart failure and sudden cardiac death. According to the company, they are the world’s smallest and thinnest high-energy devices. Further information is still sparse, as they won’t be commercially available right away. The first INCEPTAs have been implanted as part of the NOTICE-HF study, which will evaluate the results achieved with these devices, after which full commercial launch is expected to take place in the first half of next year.
Press release: Boston Scientific Announces CE Mark Approval and First Implants for New Devices to Treat Heart Failure and Sudden Cardiac Death…