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Boston Scientific Wins FDA Approval for Under-Skin Defibrillator

Boston Scientific Corp.’s Cameron Health unit won U.S. approval to sell the first defibrillator with wires that can be implanted under the skin instead of connected directly into the heart.

The Food and Drug Administration cleared the Cameron S-ICD system for use, saying in a statement today that the device provides a less invasive option for patients. Defibrillators regulate heart rhythms with an electric shock when the device detects the heart beating dangerously fast or chaotically.

Boston Scientific paid $150 million to buy Cameron in June, primarily to gain access to the new type of defibrillator, which may bolster a shrinking market for devices used to shock stopped hearts. Natick, Massachusetts-based Boston Scientific will make another $150 million payment because of the FDA approval, and the value of the acquisition to Cameron may reach $1.35 billion if certain revenue targets for the device are met.

“Some patients with anatomy that makes it challenging to place one of the implantable defibrillators currently on the market may especially benefit from this device,” Christy Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health, said in the statement.

Other implantable defibrillators require physicians to insert wires, called leads, into a vein in the upper chest and guide them into the patient’s heart.

Boston Scientific increased 1.4 percent to $5.74 at 4 p.m. New York time.

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