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FDA approves new family of shock-reducing ICDs and CRT-Ds
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The FDA has announced the approval of Medtronic’s Protecta family of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. All devices in the Protecta family are designed to reduce the incidence of inappropriate shocks.
The new ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds) are equipped with six new algorithms that recognize life-threatening arrhythmias without delivering inappropriate shocks. The new technology, called “SmartShock,” is featured in all devices in the Protecta family of ICDs and CRT-Ds.
According to a press release, the FDA approval was based on results from the Virtual ICD study, suggesting (in a statistical model) that 98% of patients implanted with SmartShock-equipped devices will be free of inappropriate shocks at 1 year after implantation, and that 92% will remain free of shocks at 5 years.
“With recent studies showing that up to one in five patients may experience inappropriate shocks, this new technology can significantly mitigate that concern and will have a real-world impact on my patients’ lives by improving quality of life,” Kent Volosin, MD, a cardiologist at the University of Pennsylvania in Philadelphia, said in the release.
The devices make use of several algorithms that deal with inappropriate shocks, including Wavelet plus PR logic; SVT discrimination in the VF zone; T-wave discrimination; lead noise discrimination; and a function called Lead Integrity Alert (designed to alert the patient of potential lead fractures).
Disclosure: Dr. Volosin reports having served as a consultant for and is a member of the speakers’ bureau for Medtronic.
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