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).  

Sign up to get our free newsletters delivered straight to your inbox

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).  

Comments

Built on an AdaptiveTheme using Drupal by Michael Knapp  mknapp