Medical device major
Boston Scientific Corporation
) recently revealed the primary endpoint results from its NEural
Cardiac TherApy foR Heart Failure (NECTAR-HF) clinical trial at the
2014 European Society of Cardiology (ESC) Congress in Barcelona,
Spain. Following the failure of endpoint results, Boston
Scientific's share price slipped 0.7% to eventually close at $12.59
Boston Scientific also plans to publish the study results in the
European Heart Journal.
The NECTAR-HF trial is the first and only randomized clinical
trial examining the efficacy of Boston Scientific's investigational
vagal nerve stimulation (VNS) device, involving sham-controlled
research method. The key purpose of this study was to evaluate the
effectiveness and safety of VNS in reducing cardiac remodeling and
improving cardiac function in symptomatic heart failure
Technically, the primary endpoint of the trial was reduction in
left ventricular end systolic diameter at the end of six months as
evaluated by a blinded echocardiography core laboratory. Secondary
endpoints involved ejection fraction, left ventricular volumes,
quality of life metrics, functional capacity, and changes in
The study examined 96 New York Heart Association (NYHA) Class
II-III patients, aged 18 years and above, suffering from left
ventricular systolic dysfunction with an ejection fraction of less
than 35%. All patients under trial continued to receive
optimal medical therapy for heart failure.
These patients were randomized in 2:1 ratio to receive medical
treatment plus an implanted active VNS device against medical
treatment plus inactive VNS device, respectively, for the six-month
However, after the completion of the control period, inactive
VNS devices were activated and all patients received the VNS
therapy. A follow-up was conducted on all patients for 18 months
with regularly reoccurring visits to achieve the safety
Results of the Study
Unfortunately for Boston Scientific, the NECTAR-HF trial failed
to significantly meet its six-month primary efficacy endpoint and
majority of its secondary endpoint measures of cardiac remodeling
and functional capacity in cardiac patients. However, the quality
of life scores revealed a notable symptomatic improvement among the
patients under trial.
Per management, administering VNS in cardiac patients failed to
churn out any positive outcome. Going by the echocardiography
derived measurements, the effect of therapy emerged no better than
Despite experiencing failure in the NECTAR-HF study, management
is optimistic that such control group studies will play a crucial
role in ramping up the efficiency of new VNS devices for heart
failure therapy in the future.
Currently, Boston Scientific has a Zacks Rank #3 (Hold).
Better-ranked stocks in the medical products industry include ICU
Medical, Inc. (
), Abaxis, Inc. (
) and Conatus Pharmaceuticals Inc. (
). While ICU Medical sports a Zacks Rank #1 (Strong Buy), Abaxis
and Conatus hold a Zacks Rank #2 (Buy).
Want the latest recommendations from Zacks Investment Research?
Today, you can download 7 Best Stocks for the Next 30 Days.
Click to get this free report
BOSTON SCIENTIF (BSX): Free Stock Analysis
ABAXIS INC (ABAX): Free Stock Analysis Report
ICU MEDICAL INC (ICUI): Free Stock Analysis
CONATUS PHARMA (CNAT): Free Stock Analysis
To read this article on Zacks.com click here.