NEW ORLEANS and MARLBOROUGH, Mass., Nov. 16, 2016 /PRNewswire/ -- Boston
Scientific (NYSE: BSX) today announced results from the first
clinical trial evaluating the performance of the HeartLogic™ Heart
Failure Diagnostic Service to predict impending heart failure (HF)
decompensation. Data collected from the Multisensor Chronic
Evaluation in Ambulatory Heart Failure Patients (MultiSENSE) study
were presented as a late-breaking clinical trial at the American
Heart Association (AHA) Scientific Sessions 2016 in New Orleans, and confirmed the HeartLogic
alert provided a highly sensitive and timely predictor of a future
HF event.
Data from the MultiSENSE trial demonstrated the HeartLogic alert
had an observed sensitivity of 70% and a low unexplained alert rate
(alerts not followed by a HF event) of 1.47 per patient per year.
Additionally, the trial data demonstrated the HeartLogic alert
could successfully notify clinicians of an associated HF event –
defined as hospitalizations with HF as the primary diagnosis and HF
outpatient treatment with intravenous therapy – 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,"
said John P. Boehmer, M.D.,
principal investigator and medical director of the Heart Failure
Program at The Pennsylvania State University
College of Medicine and The Penn State Hershey Medical
Center. "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."
The study included 900 patients who had enhanced sensor data
collection enabled in their cardiac resynchronization therapy
defibrillator (CRT-D) systems and were followed for up to one year
in either a development or test cohort. Information from the 500
patients within the development set was used to construct the
HeartLogic composite index and alert algorithm by combining heart
sounds, respiration rate and volume, thoracic impedance, heart rate
and activity. The 400 patients within the test set were sequestered
for subsequent independent validation of HeartLogic.
"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," said Kenneth Stein, M.D.,
senior vice president and chief medical officer, Global Health
Policy and Rhythm Management, Boston Scientific.
The company has submitted a design dossier for CE Mark and a
premarket approval application for U.S. Food and Drug
Administration approval of the HeartLogic service and plans to
conduct post-approval studies, including Multiple cArdiac seNsors
for mAnaGEment of Heart Failure (MANAGE-HF), to further evaluate
the alert.
The HeartLogic Heart Failure Diagnostic Service is not currently
available for use or sale.
About Boston Scientific
Boston Scientific transforms
lives through innovative medical solutions that improve the health
of patients around the world. As a global medical technology
leader for more than 35 years, we advance science for life by
providing a broad range of high performance solutions that address
unmet patient needs and reduce the cost of healthcare. For
more information, visit www.bostonscientific.com and connect on
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CONTACTS:
Laura Aumann
Boston Scientific Corporation
(651) 582-4251 (office)
Laura.Aumann@bsci.com
Susie Lisa, CFA
Investor Relations
Boston Scientific Corporation
(508) 683-5565 (office)
investor_relations@bsci.com
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SOURCE Boston Scientific