Subcutaneous ICD: A lesson in FDA approval

November 28, 2012 by MassDevice

By Westby G. Fisher, MD, FACC

Westby Fisher

This morning, a nice article in the Boston Globe appeared on Boston Scientific's subcutaneous implantable cardiac defibrillator (S-ICD)  that recently received FDA approval.  It was a fairly balanced article, one that touched ever-so-briefly on the pros and cons of a subcutaneous device to treat life-threatening cardiac arrhythmias using a medical device that does not require an internal wire inside the heart, but rather a sensing and shocking lead that is tunneled across the chest under the skin (see my prior post on the details here).  

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But what I found most interesting in the article was the patient who was recommended for the device: a dialysis patient, was a patient who was specifically excluded from the FDA trials to approve the device (specifically, patients with GFR < 29 were excluded).