Boston Scientific Receives FDA Clearance for Subcutaneous Implantable Defibrillator
Boston Scientific Corp. has announced it has received FDA approval for a new subcutaneous implantable defibrillator, according to a news release.
The S-ICD system, which Boston Scientific describes as the first commercially available subcutaneous implantable defibrillator, is designed for the treatment of patients at risk for sudden cardiac arrest. It sits just below the skin and does not require electrodes to be placed into the heart.
"With the addition of the S-ICD System, we believe Boston Scientific has a compelling and highly differentiated portfolio that will help fuel our growth strategy," said Hank Kucheman, CEO of Boston Scientific, in the release. "We are the only company to offer an FDA-approved subcutaneous implantable defibrillator and expect this to be the case for several years. The S-ICD System, coupled with our numerous recent regulatory approvals and our other innovative products … demonstrates our continued commitment to developing and bringing to market innovative products for physicians and their patients."
Boston Scientific acquired the S-ICD System earlier this year when it acquired Cameron Health. The company is planning a phased launch of the S-ICD System in the United States.
Boston Scientific is headquartered in Natick, Mass.
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