Boston Scientific touts HeartLogic study data

Boston Scientific (NYSE:BSX) today released the results from the 1st clinical trial of its HeartLogic heart failure diagnostic service, touting a high level of sensitivity and low unnecessary alert rate.

The Marlborough, Mass.-based company’s HeartLogic system is designed to predict impending heart failure decompensation.

Data from the 900-patient study reported an observed sensitivity of 70% for predicting heart failure events, with an unexplained alert rate of 1.47 per patient per year. The company said that data indicated that the HeartLogic alert could successfully notify clinicians of heart failure events with a 34-day median alert window.

“The primary endpoints were exceeded and demonstrated that this algorithm, which mimics the activity and analysis of a clinician by combining multiple measurements evaluating different aspects of heart physiology, is a strong predictor of heart failure events. The study illustrates compelling performance of the HeartLogic algorithm for the detection of worsening heart failure and lays the foundation for future studies of the alert in clinical practice,” principal investigator Dr. John Boehmer of the Pennsylvania State University College of Medicine said in a press release.

Data was collected from patients who had enhanced sensor data collection enabled on their cardiac resynchonization therapy defibrillator systems for up to 1 year.

Data from 500 patients in the development set cohort was used to construct the HeartLogic composite index and alert algorithms, using heart sound data, respiration rate and volume, thoracic impedance and heart rate and activity.

“The successful results from this study and the development of the HeartLogic service are foundational to our continued development of differentiated solutions for the management of heart failure,” chief medical officer Dr. Kenneth Stein said in prepared remarks.

Boston Scientific said it has submitted a design dossier for CE Mark and a premarket approval application with the FDA as it seeks regulatory clearance for the device, and that it has plans ot conduct post-approval studies.

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