FDA approves Boston Scientific's market-first wire-free pacemaker

October 1, 2012 by MassDevice staff

Medical device titan Boston Scientific lands FDA approval for the subcutaneous lead-free heart rhythm implant it acquired in the $1.35 billion deal for Cameron Health.

Cameron Health's subcutaneous ICD

Boston Scientific (NYSE:BSX) and newly acquired Cameron Health won FDA approval for the world's only commercially available lead-free implantable cardioverter defibrillator, the S-ICD.

Implanted just under the skin, the S-UCD is the only device of its kind that does not require wires threaded into the heart in order to provide therapy. The less-invasive device opens up the technology to a larger swath of patients.

Earlier this year an FDA expert panel voted 7-to-1 in favor of approval for the device, which Boston Scientific acquired in a merger with Cameron Health that's worth up to $1.35 billion.

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"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," Boston Scientific interim CEO Hank Kucheman said in prepared remarks. "We are the only company to offer an FDA-approved subcutaneous implantable defibrillator and expect this to be the case for several years."

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