HOUSTON, Sept. 28, 2015 /PRNewswire/ -- Cyberonics, Inc.
(NASDAQ:CYBX), yesterday announced results from the extension of
the ANTHEM-HF clinical study (ENCORE Study). Results of the
study presented by a prominent heart failure (HF) specialist during
a major cardiology congress in the United
States show that Autonomic Regulation Therapy (ART) in
patients with moderate to severe chronic HF and impaired heart
function is well tolerated, safe, improves the heart's ability to
pump blood, and reduces the frequency and severity of symptoms
associated with chronic HF. More than 10 million people in
the United States and Europe have chronic HF, a syndrome
characterized by the heart's inability to pump sufficient blood to
meet the metabolic demands of the body.
Results from the ENCORE clinical study were presented during a
Late Breaking Clinical Trials Session at the 19th Annual
Meeting of the Heart Failure Society of America (HFSA) and showed
that patients with chronic, reduced ejection fraction HF on stable
pharmacological therapy and treated with ART for 12 months via
electrical stimulation of the cervical vagus nerve experienced a
statistically and clinically significant:
- improvement in heart pump function: average left ventricular
ejection fraction increased from 33.2% at baseline to 39.5%;
average left ventricular end-systolic volume decreased 10% from 102
ml to 92 ml;
- reduction in HF symptom burden; NYHA class improved in 94% of
patients;
- improvement in quality of life (assessed by Minnesota Living
with HF Questionnaire);
- increase in functional capacity (assessed by six-minute walk
distance); and
- improvement in autonomic regulation of resting heart rate.
University of Minnesota Professor of
Medicine Inder Anand, M.D., DPhil (Oxon), Chair of the ANTHEM-HF
clinical study steering committee and until recently Director of
the Heart Failure Program, VA Medical Center, Minneapolis, Minnesota, commented, "Patients
with heart failure continue to be at high risk of increased
morbidity and mortality. They need new therapies, such as
ART, that work synergistically with evolving forms of drug
therapy. The results from the extension of the ANTHEM-HF
study presented during a Late Breaking Clinical Trials Session at
HFSA provide important insights into the safety and durability of
ART (Autonomic Regulation Therapy). During the 6- to 12-month
follow-up period, none of the patients experienced serious adverse
events related to ART, and the improvements in cardiac function
both in terms of ejection fraction and reverse remodeling suggest
that ART is ready to be tested in a randomized, control trial in
which a larger cohort of optimally-managed chronic HF patients from
the US and the EU would be randomized to a treatment group and a
control group to more extensively evaluate safety and
efficacy."
Sponsored by Cyberonics, the ENCORE study was a prospective,
multi-center, open-label, extension of the ANTHEM-HF study during
which the effects of ART were evaluated in chronic HF patients with
New York Heart Association (NYHA) Class II and III heart failure,
QRS complex interval less than 150 milliseconds, and reduced heart
pumping function (left ventricular ejection fraction less than
40%). According to investigators, patients enrolled in the
study received optimal HF pharmacological therapy prior to and
during all phases of study.
Forty-nine patients previously enrolled in the ANTHEM-HF study
elected to participate in the ENCORE study and received ART for an
additional 6 months (12 months total). All patients received
continuously-cyclic, natural-frequency ART previously described in
the publication of ANTHEM-HF results. Safety was assessed
throughout the ENCORE study and outcome measures were assessed
after 12 months of ART and compared to baseline values of the
ENCORE cohort.
"Chronic heart failure syndrome is a leading cause of death and
imposes a significant burden on health care systems throughout the
world," commented Rohan Hoare, Chief
Operating Officer of Cyberonics. "We continue to be
encouraged by the clinical benefits associated with ART and
presented by the investigators. Based on the ANTHEM-HF and
ENCORE study results, we plan to expand the commercial introduction
of our VITARIA™ System (www.VITARIAsystem.com) in
Europe and are in planning stages
for additional clinical studies."
More than 20 million people are affected with chronic heart
failure throughout the world. Patients with heart failure
experience debilitating symptoms, such as shortness of breath and
chronic fatigue. Heart failure is a progressive syndrome that
requires attentive clinical management, including occasional
hospitalization. Pharmacological therapy is standard of care;
however, morbidity and mortality remain excessive.
ANTHEM-HF study results are published in the Journal of
Cardiac Failure, 2014; 20:808-16.
About Autonomic Regulation Therapy
Autonomic Regulation Therapy (ART) increases parasympathetic
activity and thereby counteracts the sympathetic hyperactivation
that is known to commonly ensue as a compensatory response to heart
damage resulting from myocardial infarction or chronic
hypertension. Autonomic regulation of heart function reflects
the interactions between sympathetic (fight or flight response) and
parasympathetic (rest, relax response) elements of the autonomic
nervous system. In the absence of heart failure, the
sympathetic and parasympathetic nervous systems work together to
tightly regulate appropriate cardiovascular function in response to
stresses encountered during normal activities of daily
living. When HF develops and the heart pumping function
becomes impaired, the autonomic nervous system attempts to
compensate by increasing sympathetic activation and reduced central
outflow of parasympathetic activity. Initially, this
"autonomic imbalance" helps maintain cardiac output (blood supply
to body). However, prolonged sympathetic hyperactivation is
associated with maladaptive cardiovascular responses that promote
HF progression and inferior outcomes.
About Cyberonics, Inc. and the VNS Therapy®
System
Cyberonics, Inc. is a medical technology company with core
expertise in neuromodulation. The company developed and markets the
VNS Therapy System, which is FDA-approved for the treatment of
refractory epilepsy and treatment-resistant depression. The VNS
Therapy System uses an implanted medical device that delivers
electrical stimulation to the vagus nerve. Cyberonics offers the
VNS Therapy System in selected markets worldwide.
Additional information on Cyberonics and the VNS Therapy System
is available at www.cyberonics.com.
Safe harbor statement
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended and Section 21E of the Securities Exchange Act of 1934, as
amended. These statements can be identified by the use of
forward-looking terminology, including "may," "believe," "will,"
"expect," "anticipate," "estimate," "plan," "intend," "forecast,"
or other similar words. Statements contained in this press
release are based on information presently available to us and
assumptions that we believe to be reasonable. We are not
assuming any duty to update this information if those facts change
or if we no longer believe the assumptions to be reasonable.
Investors are cautioned that all such statements involve risks and
uncertainties, including without limitation, statements concerning
the conduct of additional clinical studies for the Vitaria System
for ART and expansion of the commercial introduction of the VITARIA
System. Our actual results may differ materially.
Important factors that may cause actual results to differ include,
but are not limited to: continued market acceptance of the VNS
Therapy System and sales of our products; the development and
satisfactory completion of clinical studies; the achievement of
regulatory approval for ART; adverse changes in coverage or
reimbursement amounts by the Centers for Medicare & Medicaid
Services, state Medicaid agencies and private insurers; the
presence or absence of intellectual property protection and
potential patent infringement claims by competitors; maintaining
compliance with government regulations; product liability claims
and potential litigation; reliance on single suppliers and
manufacturers for certain components; the accuracy of management's
estimates of future expenses and sales; the potential
identification of material weaknesses in our internal controls over
financial reporting; and other risks detailed from time to time in
our filings with the Securities and Exchange Commission
(SEC). For a detailed discussion of these and other
cautionary statements, please refer to our most recent filings with
the SEC, including our Annual Report on Form 10-K for the fiscal
year ended April 24, 2015 and our
Quarterly Report on Form 10-Q for the fiscal quarter ended
July 24, 2015.
Contact Information
Greg Browne, CFO
Cyberonics, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
Main: (281) 228-7262 / Fax: (281) 218-9332
ir@cyberonics.com
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SOURCE Cyberonics, Inc.