Boston Scientific this week announced the launch of a new line comprised of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems. The devices, branded under the name Resonate, merge the manufacturer’s established SmartCRT and EnduraLife battery technologies with the new HeartLogic, which has just been cleared by the FDA for conditional use in a magnetic resonance imaging (MRI) environment.
According to Boston Scientific, the HeartLogic Diagnostic tool collects data from sensors evaluating heart sounds, rate, and activity, along with patient respiration and thoracic impedance. It then uses the collected information to provide physicians with early detection of worsening heart failure in the patient. The tool is said to deliver notice a median of 34 days in advance of an impending heart failure event.
“My hope for the HeartLogic alert is that we’ll be able to better care for our heart failure patients, avoid morbid events such as heart failure hospitalizations, and actually treat the exacerbation of heart failure before the patient even knows they have it,” says John Boehmer, MD, program director of the Heart Failure Program at Penn State Hershey Medical Center and a principal investigator on a study of the HeartLogic tool.
“It’s a preemptive strike,” he adds.
The MR-conditional label carried by specific models of the Resonate family of devices is based on results from the ENABLE MRI study, completed earlier this year. The clearance also includes patients who were previously implanted with the manufacturer’s AUTOGEN, DYNAGEN, INOGEN ICD and CRT-D devices.