US Cardiologist Calls for More Data on FDA Approved Defibrillator
Published date : 03 January 2013
Article date : 03 January 2013
Medgadget reports that US cardiologist Dr. Robert Hauser, has recommended that doctors need more data on the safety and effectiveness of Boston Scientific's FDA approved lead-free implantable defibrillator, S-UCD, before using the device.
Apparently, it is the world's only commercially available lead-free implantable cardioverter defibrillator that delivers heart rate managing electrical shocks without needing wires threading through blood vessels. Implanted just under the skin, this less invasive procedure opens up the treatment to a wider range of patients.
The article quotes from Hauser's submission in the January issue of the Journal of the Americal College of Cardiology where he wrote, "The S-ICD has not yet been shown to be safe and effective in a diverse patient population." He also said that, "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."
Boston Scientific inherited the S-ICD technology last summer (2012), when it bought-out Cameron Health.
Source: 02 Medgaget 2013
