Boston Scientific announces CE mark approval and first implants for new devices to treat heart failure and sudden cardiac death


Boston Scientific announced on 19 November 2010 CE mark approval of its Incepta, Energen and Punctua cardiac resynchronisation therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs). They are the company’s latest devices to treat heart failure and sudden cardiac death.

These next-generation products are designed to advance patient care with options to expand appropriate therapy, optimise ventricular pacing and manage heart failure. They are the world’s smallest and thinnest high-energy devices and offer extended longevity over legacy platforms.

The first implants of Incepta ICDs and CRT-Ds occurred in Berlin, Germany at the Deutsches Herzzentrum Berlin (Stephan Goetze, professor of Medicine); Herne, Germany at the Katholisches Marienhospital Herne (Hans-Joachim Trappe, professor of Medicine); Linz, Austria at the Krankenhaus der Elisabethinen Linz (Siegmund Winter); and Maastricht, The Netherlands at the Academisch Ziekenhuis Maastricht (An Moens). These initial implants are part of the NOTICE-HF study, which will evaluate and document the performance of the devices before full commercial launch, expected in the USA, the Europe/Middle East/Africa region and certain inter-continental countries in the first half of next year.

“These devices offer physicians and their patients more options to customise therapy with new features designed to identify patient risks, while improving pacing and simplifying the implant,” said Goetze, the principal investigator of the NOTICE-HF study.

“Boston Scientific looks forward to making these devices available to physicians and their patients,” said Hank Kucheman, executive vice president and president of Boston Scientific’s Cardiology, Rhythm and Vascular Group. “This new portfolio of products, built on our tradition of innovation, provides multiple therapy options designed to match specific patient needs.”