DALLAS and MARLBOROUGH, Mass., Sept. 19, 2017 /PRNewswire/ -- Boston
Scientific (NYSE: BSX) today announced new data from the
Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients
(MultiSENSE) study evaluating the performance of the HeartLogic™
Heart Failure Diagnostic to predict impending heart failure (HF)
decompensation. Data from the study were presented as a
late-breaking clinical trial at the Heart Failure Society of
America's 21st Annual Scientific Meeting in Dallas, and confirmed the HeartLogic
Diagnostic accurately enhanced the ability to classify patients at
high or low-risk of experiencing a future HF event.
The HeartLogic Diagnostic provides continuous measurement of a
patient's heart failure by combining data from sensors evaluating
heart sounds, respiration rate and volume, thoracic impedance,
heart rate and activity. Current clinical guidelines recommend the
use of a blood test to measure natriuretic peptides BNP or
NT-proBNP in order to diagnose HF or determine disease
severity.1,2 However, the test can only reflect a
snapshot assessment at the time of a blood draw, which loses
relevance as a patient's condition changes.
New data from the MultiSENSE trial demonstrated the HeartLogic
Diagnostic significantly expanded the ability of a baseline blood
test to identify when patients were at an elevated risk of a HF
event. The combination of the HeartLogic Diagnostic with a baseline
NT-proBNP measurement accurately identified when patients within
varying risk groups were at a 23 to 50 times increased risk of
experiencing a HF event.
"Through the utilization of the HeartLogic Diagnostic,
physicians can more accurately triage appropriate care to this
vulnerable patient population in a timely manner, particularly when
using the alert in combination with an intermittent measure of
NT-proBNP," said John P. Boehmer,
M.D., principal investigator and director of the Heart Failure
Program at Penn State Health Milton S. Hershey Medical Center and
professor of medicine, Penn State College of
Medicine.
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.
"The data presented today further prove the value of the
HeartLogic Diagnostic in the early prediction of HF events," said
Kenneth Stein, M.D., senior vice
president and chief medical officer, Global Health Policy and
Rhythm Management, Boston Scientific. "Our commitment to innovation
in heart failure remains steadfast, and we look forward to the
seeing continued results of the alert in a clinical setting."
Previously published study data demonstrated that the HeartLogic
Diagnostic had an observed sensitivity of 70% as well as the
ability to provide weeks of advance notice and low burden for
detecting indications of worsening HF.3
The company received CE Mark and U.S. Food and Drug
Administration approval of the HeartLogic Diagnostic within the
Resonate™ family of implantable cardioverter defibrillator and
CRT-D systems earlier this year. The new line of devices will
become commercially available later this year.
For more information on the HeartLogic Heart Failure Diagnostic,
visit www.bostonscientific.com/heartlogic.
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
Twitter and Facebook.
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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
1 Yancy CW, Jessup M, et al. 2017 ACC/AHA/HFSA
focused update of the 2013 ACCF/AHA guideline for the management of
heart failure: a report of the American College of
Cardiology/American Heart Association Task Force on Clinical
Practice Guidelines and the Heart Failure Society of America.
Circulation. 2017;136:e137–e161. DOI:
10.1161/CIR.0000000000000509.
2 Ponikowski P, Voors AA, et al. 2016 ESC Guidelines for
the diagnosis and treatment of acute and chronic heart failure. The
Task Force for the diagnosis and treatment of acute and chronic
heart failure of the European Society of Cardiology (ESC). European
Heart Journal 2016;37:2129-2200.
3 Boehmer, J et al., JACC-HF, 2017;5(3),2 1 6 – 2
56.
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SOURCE Boston Scientific