TY - JOUR AU1 - AB - NBSv40n18_NBS 9/14/10 10:06 AM Page 137 Biomedical Safety & Standards Concise, accurate news reports for medical device safety professionals BS&S FEATURE October 15, 2010 Volume 40 Number 18 New Subcutaneous Defibrillator Eliminates Transvenous Leads IN THIS ISSUE A new implantable cardioverter-defibrillator (ICD) has been approved in Product Hazard & Europe and is undergoing trials in the United States. The revolutionary device Clinical Safety works more like an external defibrillator, in that it does not require venous Warning on Dermatome access—the ICD is implanted under the skin. Instruments ....................137 Will fractured electrical leads become a distant memory? Recalls & Field Corrections—Class I The subcutaneous device was developed at the Seattle Institute for Cardiac St. Jude Medical Engage Research. After testing various configurations and energy requirements, the devel- Introducers ....................139 opers settled on a parasternal electrode with a left lateral thoracic pulse generator. Cook Medical Tracheostomy Kits ................................139 A recent article in the New England Journal of Medicine describes clini- Inomax DS Drug Delivery cal studies that demonstrated the subcutaneous ICD was as effective as a System ............................139 transvenous ICD for terminating induced ventricular fibrillation. During the Recalls & Field 10-month study period, the device successfully detected and treated all Corrections—Class TI - Warning on Dermatome Instruments JF - Biomedical Safety & Standards DO - 10.1097/01.BMSAS.0000388873.36566.57 DA - 2010-10-01 UR - https://www.deepdyve.com/lp/wolters-kluwer-health/warning-on-dermatome-instruments-VvPPy2KG8F VL - 40 IS - 18 DP - DeepDyve ER -