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FDA approves line of ICDs, CRT-Ds for patients with heart failure
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Boston Scientific announced that the FDA has approved its new line of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillator systems.
The new line of devices (Resonate) includes technology for multielectrode pacing (SmartCRT) and compatibility with a diagnostic service (HeartLogic) for HF management, according to a press release issued by the company.
The devices have nearly twice the battery life compared with certain existing devices, reducing the prevalence of device replacement procedures, the company stated in the release.
The National Institute for Health and Care Excellence in the United Kingdom recently issued guidance that suggests the use of CRT-D with the battery technology (EnduraLife) for improved outcomes and potential healthcare savings, according to the release.
The company stated it has started three clinical trials, SMART CRT Study, SMART Registry and SMART MSP, to validate the devices’ effects on CRT therapy and their ability to inform physicians on when to pace the lower heart chambers.
“These trials will add to the body of evidence showing CRT therapy can be tailored to individual patient characteristics at the time of implant, while adjusting device programming solutions over the life of the device without fear of adversely draining the device battery and causing unnecessary replacement procedures,” Michael R. Gold, MD, PhD, professor, associate dean of interdisciplinary clinical programs and Michael E. Assey Chair in cardiology at the Medical University of South Carolina in Charleston, principal investigator of the SMART CRT Study and president of the Heart Rhythm Society, said in a press release.
Disclosure: Gold reports receiving research funding from Boston Scientific and St. Jude Medical.