Two months after federal regulators approved the first defibrillator that can be placed under the skin instead of connecting directly to the heart, doctors at Brigham and Women's Hospital implanted three of the new devices Monday in patients at risk of cardiac arrest.
The procedures marked the first New England implantations of the subcutaneous heart defibrillator, or S-ICD, built by Natick-based Boston Scientific Corp. Doctors call it a breakthrough treatment in preventing sudden cardiac fatalities, the most common cause of death in the United States.
"This is a major advance, the most significant advance in the technology in years," said Dr. Laurence M. Epstein, chief of the arrhythmia service at Brigham and Women's in Boston and associate professor of medicine at Harvard Medical School, who implanted the second and third defibrillators. The first was implanted by his colleague, Dr. Bruce A. Koplan.
All were given to patients who were deemed likely candidates for cardiac arrest, but couldn't tolerate standard cardiac defibrillators, which run a wire — or lead — through veins into the heart. The wire is attached to an implanted defibrillator, which can send an electric shock to the heart to treat arrhythmia, an abnormally fast or chaotic heartbeat in patients.
But such leads sometimes need to be extracted because of infections. Epstein said he expects the S-ICD, a less invasive treatment that delivers the shock without inserting a wire into the heart, could be used in 10 to 20 percent of patients.
Boston Scientific estimates the new device eventually could generate annual sales of $750 million to $1 billion worldwide, company spokesman Steve Campanini said Monday. The product, considered one of Boston Scientific's "key growth drivers," was acquired when the medical device company purchased Cameron Health Inc. of San Clemente, Calif., last March.
Anthony Andrews, a 36-year-old information technology worker from Gloucester, received the first implant Monday morning at Brigham and Women's, which has one of the largest arrhythmia services in the nation and is considered a go-to site for pioneering new cardiac technologies.
Andrews said his doctors recommended implanting a defibrillator because of his family history and because he currently receives dialysis treatments, but he had been reluctant to use a standard model for fear of infection. When he learned last month that the Food and Drug Administration had approved a product "with no leads into my heart," Andrews said he immediately chose that route.
"The doctors and I bantered back and forth about how and when to implant a defibrillator," Andrews said. "This procedure was the best option for me to prolong my longevity."
For physicians, the S-ICD represents a new option for combating cardiac arrest, which causes between 350,000 and 450,000 deaths in the United States each year, Epstein said.
But he cautioned that the cardiac device has imitations because it currently can only be used for ventricular fibrillation — when the heart beats too rapidly. Standard defibrillators, which also act as pacemakers, can adjust to pace the heart when it is beating too slowly.
Robert Weisman can be reached at email@example.com.