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Cameron Health starts ICD trial

This article was originally published in The Gray Sheet

Executive Summary

Firm begins a pivotal study March 18 to support FDA approval efforts for its subcutaneous implantable cardioverter defibrillator (S-ICD) system for patients at risk of sudden cardiac arrest. The device does not require leads in or near the heart. In addition, because components are positioned using anatomical landmarks, the S-ICD does not require imaging equipment to place the implant. FDA has granted an investigational device exemption for the study, which will enroll up to 330 subjects at up to 35 sites globally, including the U.S. New Zealand was among the first sites to test the S-ICD (1"The Gray Sheet" June 8, 2009)

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