Hauser curbs enthusiasm for Boston Scientific's lead-free implanted defibrillator

January 2, 2013 by MassDevice staff

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.

Cameron Health's S-ICD

Frequent medtech challenger Dr. Robert Hauser offered some words of warning for physicians clamoring over Boston Scientific's (NYSE:BSX) wire-free implantable defibrillator: curb your enthusiasm.

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."

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Implanted just under the skin, the S-UCD is the only device of its kind that does not require wires threaded into the heart in order to provide therapy. The less-invasive device opens up the technology to a larger swath of patients.

The S-ICD system won CE Mark approval in the European Union in 2009 and has been on the market outside for some time. More than 1,400 devices have been implanted in patients around the world to date, according to Boston Scientific.

Boston Scientific acquired the S-ICD technology last summer when it acquired Cameron Health in a deal worth $1.35 billion.