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Boston Scientific gets subpoena about defibrillators

Boston Scientific gets subpoena about defibrillator performance

By Jaimy Lee
Posted: May 9, 2014 - 1:45 pm ET

Boston Scientific Corp., a Natick, Mass.-based manufacturer of implantable cardiac devices and other medical products, said it was served with a subpoena from HHS' Office of the Inspector General for information about the performance of its defibrillators.

The company disclosed the May 5 subpoena in securities filings and said it is cooperating with the request. The government is seeking information about the launch and performance of the Cognis and Teligen line of devices. It also requested material about the operation of what was referred to as a physician-guided learning program.

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Boston Scientific launched its Cognis cardiac resynchronization therapy defibrillator and its Teligen implantable cardioverter defibrillator in 2008.

Implantable cardioverter defibrillators, commonly referred to as ICDs, are implanted into the chest or abdomen and are used to control arrhythmias, including those causing sudden cardiac arrest.

Boston Scientific recently reported that sales of defibrillators fell to $208 million in the first quarter of 2014, compared with $221 million in the same quarter a year ago. Procedures involving ICDs, which cost about $40,000, also have been investigated by the Justice Department over concerns that some patients undergoing these surgeries do not benefit from them.

The company also makes pacemakers and stents.

Follow Jaimy Lee on Twitter: @MHjlee

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