Boston Scientific won approval from the FDA and is launching its Resonate line of implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D). The implants include the firm’s HeartLogic diagnostic capability that sends an alarm to the cardiologist if it believes the patient’s heart is exhibiting worse performance, which may lead to a serious event such as an infarct.
HeartLogic relies on a number of sensors within the implant that provide data on heart sounds, heart rate, breathing rate and volume, thoracic impedance, as well as the patient’s current physical activity levels. Of particular curiosity to us is the fact that the Resonate implants actually listen to heart sounds, which would imply that there’s some sort of microphone inside these devices. According to Boston Scientific, the HeartLogic alert system has shown to have a sensitivity of 70% detecting worsening heart failure and sometimes predicting serious cardiac events many weeks before they happen. In a recent study, it issued a warning on median 34 days before such events happened.
With the help of multi-electrode leads, the Resonate implants also provide SmartCRT Technology that offers options to pace different parts of the heart in different ways. The devices can be set to deliver different pacing signals depending on the patient’s time and location, and other parameters. A smart battery management system helps to adjust the signals to get the most out of the onboard battery without limiting the device’s capabilities.
Finally, many of the Resonate devices are also safe to go inside MRI machines up to 1.5 Tesla, as long as precautions are taken. This lets patients continue to receive magnetic resonance scans following implantation, an important option to keep open for patients with heart failure.
From Boston Scientific:
This capability extends beyond the Resonate family and includes those patients who were previously implanted with AUTOGEN™, DYNAGEN™, INOGEN™ ICD and CRT-D devices. MRI approval was based on clinical trial results from the global ENABLE MRI study, which was completed earlier this year.
The company recently began enrolling patients in the MANAGE-HF study to evaluate further the HeartLogic Diagnostic and has initiated a series of clinical trials to demonstrate improved response to CRT therapy with the SmartCRT Technology.
“Through the MANAGE-HF study we will be able to realize fully the capabilities of the HeartLogic Diagnostic in clinical practice,” said Dr. Adrian Hernandez, principal investigator of the MANAGE-HF study, director of health services and outcomes research at the Duke Clinical Research Institute and vice dean of clinical research at Duke University School of Medicine. “We look forward to collecting additional data on how the alert can enable improved patient outcomes.”
Related study in JACC: Heart Failure: A Multisensor Algorithm Predicts Heart Failure Events in Patients With Implanted Devices…
Via: Boston Scientific…