Boston Scientific Corp. on Friday announced that the Food and Drug Administration has approved the world's first commercially available heart defibrillator that does not use leads, the thin insulated wires that sometimes have failed in other defibrillators, prompting recalls.
Boston Scientific's new device -- the subcutaneous implantable defibrillator (S-ICD) -- is positioned just below the patient's skin and can restart the heart without connecting the device with leads that run through blood vessels.
"Doctors now have a breakthrough treatment option that provides protection from sudden cardiac arrest without touching the heart," said Dr. Raul Weiss, associate professor of medicine at Ohio State University.
Federal approval of the Boston Scientific system has been expected for weeks, and it could be a major player in the worldwide market of heart defibrillators, commonly called ICDs. For Boston Scientific, which is based in Natick, Mass., and employs 5,000 workers in Minnesota, the new S-ICD could mean $750 million to $1 billion in revenue, said CEO Hank Kucheman.
Some patients who choose the new device will be turning away from ICDs that use leads, Kucheman said. But he predicted that his company's innovation will expand the market by attracting new customers who were scared away from ICDs because of worries about lead-related problems.
"Research says this technology has the potential to expand the market and increase referrals in patient choice," Kucheman said. "This will not only increase our share of the pie. This will make a new pie."
Boston Scientific expects to begin a phased launch of the S-ICD system that will expand over time as doctors are trained in its use. The company acquired the S-ICD system earlier this year when it completed the acquisition of Cameron Health Inc. S-ICD has been commercially available in many countries in Europe as well as in New Zealand. More than 1,400 devices have been implanted in patients around the world.
Thomas Gunderson, a senior analyst with Piper Jaffray & Co., said the S-ICD could take 5 to 20 percent of the current defibrillator market, which produces more than $6.5 billion in annual sales worldwide.
"The device could represent the beginning of a new category that, as Boston Scientific says, could expand the market, maybe significantly," he said. "No one really knows."
Sudden cardiac arrest is an abrupt loss of heart function. Most episodes are caused by the rapid and/or chaotic activity of the heart known as ventricular tachycardia or ventricular fibrillation. Boston Scientific said recent estimates show that approximately 850,000 people in the United States are at risk of sudden cardiac arrest.
Leads carry lifesaving therapy from pacemakers and ICDs through veins and into the heart. Studies have shown that about 20 percent of patients have some kind of lead-related complication eight to 10 years after implant, Kucheman said. In part, that's because the circulatory system can be a challenging environment for leads: The heart beats about 32 million times a year.
Little Canada-based St. Jude Medical Inc. pulled its popular Riata leads off the market in December 2010 and the FDA issued a recall of the device in late 2011. Earlier this year, the company announced that it was pulling two other pacemaker leads off the market because of reports of wires working through outer insulation.
In 2007, Medtronic Inc. pulled its Sprint Fidelis lead off the market after a study found that some of the wires failed. Aggrieved patients eventually won a $114 million settlement from the Fridley-based company.
Boston Scientific's S-ICD features a sensing device and an electrode that are placed under the skin alongside the breastbone.
The S-ICD would benefit younger patients who have long life expectancies and patients for whom the risk of complications from having leads in their vascular systems is high, said Dr. Michael Gold, chief of cardiology at the Medical University of South Carolina.
"Leads are clearly the weak link of the system," he said. "Leads are often the Achilles heel of long term therapy."
Lisa Callis Williams, 36, is one of those patients for whom leads did not work. She had her first defibrillator implanted in 2005 after she was deemed a high risk for sudden cardiac arrest.
About a year after the ICD was implanted, her body began reacting to the leads. Then she received inappropriate shocks due to lead failure. She became part of the clinical trial and was among the first to use the S-ICD.
She has gone two years, with no complications, she said.
"I still have my heart disease, but as far as the device goes, this is definitely ideal for me," Callis Williams said. "If they have to pull this lead out, it is literally right under my skin. It is not invasive."
James Walsh 612-673-7428