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| Boston Scientific's S-ICD lead system--Courtesy of Boston Scientific |
Boston Scientific ($BSX) played up a data registry study in the Journal of the American College of Cardiology demonstrating the safety of its subcutaneous implantable defibrillator, which is the only device of its kind without leads that come into direct contact with the heart.
Among the 889 patients and 1,571 patient-years of follow-up there were no lead failures and no systematic infections associated with the S-ICD. The rate of complications was 11% at three years, compared to 9% at year one and 10% at year two, Boston Scientific said.
The all-cause mortality rate for S-ICD patients was 1.6% per year, based on data from the S-ICD's premarket clinical trial and the Effortless international data registry. The device was FDA approved in 2012 and CE marked in 2009.
"The S-ICD device sits just below the skin without the need for electrodes or leads to be placed into the heart and so it makes sense that we see decreased serious complications," said study leader Dr. Martin Burke, a professor of medicine at the University of Chicago. "By using the S-ICD System we can avoid the key risks that cause systemic or endovascular infections, which can add weeks to a hospital stay, incur tens of thousands of dollars in incremental hospital costs, and which are also associated with mortality for up to one-third of TV-ICD patients who acquire this type of infection."
Safety has always been the device's main selling point, as conventional leads, or wires used to deliver electrical impulses, have been associated with multiple patient deaths and recalls over the years because the wires wore through their external insulation in some cases.
In February, St. Jude Medical ($STJ) agreed to pay as much as $14.25 million to settle about 950 claims related to its Riata defibrillator leads. The wires used to shock a heart that is beating abnormally degraded in as few as four years and were pulled from the market in 2010. Medtronic's ($MDT) Fidelis leads were hit with four Class I recalls in 2007.
The fast-selling S-ICD has shown the potential of cardiology devices that are less reliant on potentially hazardous leads. Sales of the S-ICD topped $100 million in Q4 2014. And last month Boston Scientific launched the next-generation Emblem S-ICD, which the company says is 19% thinner and lasts 40% longer than its predecessor.
Competitors in the distinct but related pacemaker market are scrambling to develop a leadless version of that device.
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