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New Products In Brief

Recent new product launches and approvals include Boston Scientific’s novel S-ICD subcutaneous implantable cardioverter defibrillator, Globus Medical’s Secure-C artificial cervical disc and ConforMIS’ next-generation iTotal G2 total knee replacement.

Boston Scientific Corp. plans a phased U.S. launch of its novel S-ICD subcutaneous implantable cardioverter defibrillator following PMA approval Sept. 28, the company said. The device, which is designed to treat ventricular tachyarrhythmias in patients at risk of sudden cardiac arrest, is the first subcutaneous ICD available in the U.S. The product, available in Europe since 2009, eliminates the need to thread wire ICD leads into the heart. It received a favorable FDA panel vote in April. (See Also see "Cameron Health’s Subcutaneous ICD Gains FDA Panel Endorsement" - Medtech Insight, 30 April, 2012..)

Boston Scientific, which had expected to receive FDA approval in the first half of 2013, gained the technology earlier this year through its acquisition of privately held Cameron Health. The...

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