August 26th, 2013
New Subcutaneous ICD Said to Pose ‘Existential Crisis’ for Older ICDs
Larry Husten, PHD
Last year the FDA approved Boston Scientific’s subcutaneous ICD (S-ICD), the first ICD that doesn’t use transvenous leads. Those leads are the source of many sophisticated pacing features in today’s ICDs, but they are also the main source of ICD-related complications. FDA approval of the S-ICD was based on a pivotal trial designed to assess the […]
September 28th, 2012
Subcutaneous ICD Gains FDA Approval
Larry Husten, PHD
The FDA today approved the Subcutaneous Implantable Defibrillator (S-ICD) System from Cameron Health. The device is the first ICD that does not require a lead that connects directly to the heart and therefore does not need to be guided by X-ray fluoroscopy. Instead, the S-ICD lead is implanted along the bottom of the rib cage […]
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