WASHINGTON — The Food and Drug Administration says it has approved a first-of-a-kind heart-zapping implant from Boston Scientific that that does not directly touch the heart.
Implantable defibrillators use thin wires to send electrical signals that disrupt dangerous heart rhythms. Surgeons have traditionally connected the wires to the heart through a blood vessel in the upper chest.
The new device from Boston Scientific uses wires that sit just below the skin’s surface and do not need to be threaded through the heart’s blood vessels.
Natick, Mass.-based Boston Scientific Corp. acquired the device through a $150 million buyout of San Clemente, Calif.-based Cameron Health. Under the terms of the deal, Boston Scientific will pay an additional $150 million for FDA approval, plus up to $1 billion in payments based on future sales figures.