Hauser curbs enthusiasm for Boston Scientific's lead-free implanted defibrillator
Noted cardiologist and frequent medtech critic Dr. Robert Hauser warns that doctors need more data on the safety and effectiveness before widely accepting Boston Scientific's newly acquired and FDA approved lead-free implantable defibrillator.
The device, which won FDA approval last year, is the world's only commercially available lead-free implantable cardioverter defibrillator, delivering heart rate managing electrical shocks without needing wires threaded through blood vessels.
"The S-ICD has not yet been shown to be safe and effective in a diverse patient population," Hauser wrote in the January issue of the Journal of the American College of Cardiology. "Unless critical questions with regard to safety and efficacy in primary and secondary prevention are addressed, the S-ICD should be confined to certain subgroups."