CHICAGO Jan 2 Boston Scientific Corp's
new leadless implantable heart defibrillator, hailed by some as
a breakthrough, should be used on a limited basis until more
data are collected, a prominent cardiologist wrote in an
editorial of a top medical journal.
Leads, or wires that carry electrical pulses from the
defibrillator - which is implanted in the chest - to the heart
have always been the weak link in these systems, used to treat
irregular heart beats. All of the device makers have had
problems at one time or another with leads.
Boston Scientific bought the leadless technology, known as a
subcutaneous implantable cardioverter-defibrillator, or S-ICD,
when it acquired Cameron Health last year. The Cameron device
was approved by the U.S. Food and Drug Administration in the
"The S-ICD has not yet been shown to be safe and effective
in a diverse patient population," Robert Hauser wrote in the
January issue of the Journal of the American College of
Hauser, of the Minneapolis Heart Institute who has been a
vocal critic of medical device companies, also noted that the
leadless ICD has not even been shown to be as good as the
traditional ICDs that use leads.
He said the technology is a promising one that could fill
important gaps, especially by bringing it to countries where
facilities to implant traditional devices is not available, but
more data are needed first.
"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," he said.
Boston Scientific was not immediately available to comment.