Dr. Robert Hauser, an outspoken cardiologist who frequently clashes with medtech companies, issued a warning on a new defibrillator by Boston Scientific. According to Reuters, Dr. Hauser has issued a warning over limited safety and efficacy data for the device. The new lead-free defibrillator by Boston Scientific has already been approved by the United States Food and Drug Administration.
As of now, Boston Scientific’s new device is the only lead-free defibrillator on the market to receive FDA approval. The device uses electrical shocks to manage heart rate without the use of wires implanted in blood vessels.
In the Journal of the American College of Cardiology, Dr. Hauser said, “"The S-ICD has not yet been shown to be safe and effective in a diverse patient population." He continued, "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."
The less-invasive S-ICD by Boston Scientific is designed to be implanted directly under the skin. Since there is no need to run wires through a patient’s blood vessels, more patients may qualify for implantation. The European Union has already granted CE Mark approval for the device in 2009. The device has been used in over 1,400 patients, according to information from Boston Scientific.
S-ICD technology was acquired by Boston Scientific in 2012 during a $1.35 billion acquision of Cameron Health.
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