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Leading cardiologist urges caution with new leadless defibrillator devices

Jan 3, 2013

A leading and outspoken cardiologist is again urging caution on the use of a new implanted cardiac defibrillator device.

According to a Reuters report this week, Dr. Robert Hauser writes in the most recent edition of Journal of the American College of Cardiology that Boston Scientific's new cardiac defibrillator device that does not use lead wire technologies to deliver shocks to a recipient's heart, a device known as a subcutaneous implantable cardioverter-defibrillator (S-ICD).

Boston Scientific acquired the rights to these devices when it purchased Cameron Health in 2012. The Food and Drug Administration only recently approved the device in the final quarter of 2012 and did so among swirling controversies over the class of implanted cardiac defibrillator devices.

Implanted defibrillators typically rely on small wires connecting from the device to a recipient's heart. The defibrillators are designed to either deliver shocks to keep a heart beating or timed pulses to regulate a heart rhythm. Problems with these lead wires has resulted in hundreds of serious injuries and deaths to recipients of the devices. In at least one instance, with another company's specific type of lead wire, the lead was prone to breaking free of its protective housing on the conductive end of the lead wires. 

These defects led to defibrillators not delivering shocks when they were supposed to or delivering unnecessary shocks as well as internal injuries like lacerations to the heart and other sensitive organs near the defibrillator. 

Hauser, who is employed as a cardiologist at Minneapolis Heart Institute and works independently as a medical devices researcher, has previously issued public statements through medical journals regarding his skepticism of other implantable cardiac defibrillator devices, including the recalled St. Jude Riata, Riata ST, and other devices. Reuters reports that Hauser has again signaled an alarm regarding these new leadless defibrillators.

For people who believe they may be at risk of suffering from the failures of their defective cardiac defibrillator or for those who must now weigh their options with a new device, many may believe that a new and "wireless" device may be best. He writes in his journal entry: "The S-ICD has not yet been shown to be effective in a diverse patient population. 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."

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