Boston Scientific: FDA approves 3 heart devices
Thursday, December 1, 2011
NATICK, Mass. (AP) — Boston Scientific Inc. said Wednesday the Food and Drug Administration approved several new implantable heart devices the company developed.
The company said the FDA approved devices that will be marketed under the names Incepta, Energen and Punctua devices. All three product lines include implantable cardioverter defibrillators, which are used to treat rapid heartbeats, and cardiac resynchronization devices, which include an ICD and a resynchronization device used to coordinate the pumping of the heart.
The company says the devices are smaller and thinner than older heart implants, and that they are easier to implant and less visible from the outside. Boston Scientific said the first Incepta implant occurred Tuesday.
European regulators approved the Energen and Punctua product lines in October 2010, and they have been on sale in Europe and other non-U.S. markets since May.