Boston Scientific (NYSE:BSX) launched today its Resonate implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator systems with the HeartLogic heart failure diagnostic tool.
The devices are approved by the FDA for conditional use in an MRI environment, the company reported.
Boston Scientific’s HeartLogic diagnostic warns doctors of worsening heart failure, collecting data from sensors monitoring heart sounds, thoracic impedance, heart rate and activity and respiration rate and volume.
The company touted its alert system as the first and only of its kind in an implantable device with an observed sensitivity of 70% and the ability to provide weeks of advance notice.
“The HeartLogic Diagnostic provides physicians the ability to pivot from reactive heart failure treatment to proactive care with a goal of improving patient outcomes and reducing heart failure-related hospitalizations,” Dr. Kenneth Stein, SVP & CMO of Boston Scientific’s rhythm management and global health policy unit, said in prepared remarks. “We believe the new features included in this family of devices offer physicians an unprecedented level of confidence when caring for patients with heart failure.”
The CRT-Ds in the Resonate portfolio also feature SmartCRT technology, the company reported, which allows doctors to customize where, when and how to pace the lower chambers of the heart.
Boston Scientific has started recruiting patients for the Manage-HF study, which is designed to further evaluate the HeartLogic diagnostic and has also launched a number of trials to assess patients’ responses to CRT therapy with SmartCRT technology.
“Through the Manage-HF study we will be able to realize fully the capabilities of the HeartLogic Diagnostic in clinical practice,” principal investigator Dr. Adrian Hernandez added. “We look forward to collecting additional data on how the alert can enable improved patient outcomes.”
The Resonate devices, as well as the company’s Autogen, Dynagen and Inogen ICD and CRT-D devices, feature MR-conditional labeling, which allows patients to receive full-body MR scans in 1.5 Tesla environments.