|Boston Scientific's S-ICD--Courtesy of Boston Scientific.|
Prominent cardiologist Robert Hauser has been known to ruffle feathers in the medical devices industry--and with his recent admonition of Boston Scientific's ($BSX) FDA-approved leadless subcutaneous implantable cardioverter-defibrillator, he carries on that role.
Hauser thinks it's too soon to celebrate the September approval of the device, also known as an S-ICD, the first of its kind to gain U.S. approval. In a January opinion article in the Journal of the American College of Cardiology, Hauser writes that "there are no data showing equivalency--much less superiority--in patients at high risk for sudden cardiac death" and that the S-ICD has yet to prove safe and effective in a diverse population.
Hauser believes that the results of the FDA's IDE study are "encouraging" but that the S-ICD should be limited to patients without venous access or to children and active adults in whom transvenous leads might be more prone to fail. And because of the S-ICD's lack of a pacing mechanism, it can be uncomfortable and possibly dangerous to those patients who require one, he writes.
Ken Stein, chief medical officer of Boston Scientific's Cardiac Rhythm Management unit, said Wednesday that having a leadless device that lacks a pacing mechanism is a deliberate design choice trade-off. Stein said on behalf of Boston Sci that the S-ICD was not intended to meet every patient's needs.
"The truth is there's much in Dr. Hauser's piece we agree with," Stein said. "It's very important to recognize this device is not for everyone, but from my standpoint, he agrees there are groups of patients that benefit."
Boston Sci is coming off a difficult year due to a slump in its cardiac rhythm management and interventional cardiology business lines. The company held on as its stock plummeted mid-year, waiting for its $150 million purchase of Cameron Health to pay off. The S-ICD is Cameron's signature product, and Boston Sci is heavily invested in the device's market success.
- here's the JACC piece