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."
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.
A vocal critic of the medical device industry, Hauser raised questions about the level of safety and effectiveness data available on the S-ICD system, which he warned hasn’t been demonstrated to be on par with traditional ICDs, Reuters reported.
Hauser has made himself well-known among medical device circles, most recently taking a starring role in a contentious public battle over St. Jude Medical‘s (NYSE:STJ) recalled Riata defibrillator leads.
He unleashed a firestorm of controversy with a study that linked rival lead-maker Medtronic’s(NYSE:MDT) Quattro Secure leads with only 5 lead-related deaths, compared with 22 for St. Jude’s Riata.
Hauser, who was 1 of the physicians who helped uncover problems with Guidant Corp.’s pacemakers after a patient he was treating died, is also a vocal critic of the FDA’s policies regarding post-market surveillance and has said that he considers the high-profile Riata recall a defect that should have been caught sooner.
