Neovasc Comments on Journal of the American Heart Association Publication
February 05 2021 - 9:00AM
via NewMediaWire -- Neovasc, Inc. ("Neovasc" or the "Company")
(NASDAQ, TSX: NVCN) today announced that the Journal of the
American Heart Association has published an article
entitled, “Angina Severity, Mortality, and Healthcare
Utilization Among Veterans with Stable Angina”. The prestigious
journal is the official publication of the American Heart
Association, and the article offers important insights into the
burden of angina on both patients and healthcare systems.
The article, authored by Mina Owlia, M.D., New York University
School of Medicine, explored the relationship between Canadian
Cardiovascular Society (CCS) angina severity classification and
all-cause mortality and healthcare utilization. The retrospective
analysis of veterans in the United States utilized natural language
processing to identify over 14,000 patients suffering from
angina.
The study found that patients suffering from angina had worse
outcomes and higher rates of healthcare utilization than patients
without angina. Importantly, patients with more severe classes of
angina, CCS III & IV, had markedly worse outcomes than CCS I
& II. During a median follow-up of 3.4 years, all-cause
mortality rates were 4.58, 4.60, 6.22, and 6.83 per 100 person
years for CCS classes I, II, III, and IV, respectively.
Multivariable adjusted hazard ratios for all-cause mortality
comparing CCS II, III, and IV with those in class I were 1.05 (95%
CI, 0.95–1.15), 1.33 (95% CI, 1.20–1.47), and 1.48 (95% CI,
1.25–1.76), respectively. Hospitalizations, stenting procedures and
bypass graft surgeries were also more likely to occur in patients
with the most severe classes of angina.
“Angina is a predictor of poor outcomes for patients and as
indicated in this large study, CCS classification as used in the
original Reducer COSIRA study was indeed a very good measure to
focus on,” said Fred Colen, Chief Executive Officer of Neovasc.
“CCS classification in this study was positively
associated with all-cause mortality and
healthcare utilization for cardiovascular causes. Compared with CCS
class I, those with CCS class III or IV angina symptom severity
near the time of angina diagnosis experienced a 33% to 48% higher
all-cause mortality rate over the median 3-year follow-up in this
study. Furthermore, the incremental costs for the healthcare system
associated with CCS classes III and IV, compared to CCS class I
were over $6000.00 per year higher in this study.” He
continued, “We would like to thank the authors for their important
contribution to the understanding of the consequences of angina and
encourage others to continue to study the burden of the
condition.”
About Reducer
The Reducer is CE-marked in the European Union for the treatment
of refractory angina, a painful and debilitating condition that
occurs when the coronary arteries deliver an inadequate supply of
blood to the heart muscle, despite treatment with standard
revascularization or cardiac drug therapies. It affects millions of
patients worldwide, who typically lead severely restricted lives as
a result of their disabling symptoms, and its incidence is growing.
The Reducer provides relief of angina symptoms by altering blood
flow within the myocardium of the heart and increasing the
perfusion of oxygenated blood to ischemic areas of the heart
muscle. Placement of the Reducer is performed using a minimally
invasive transvenous procedure that is similar
to implanting a coronary stent and is completed in
approximately 20 minutes.
While the Reducer is not approved for commercial use in the
United States, the FDA granted Breakthrough Device designation to
the Reducer in October 2018. This designation is granted by the FDA
in order to expedite the development and review of a device that
demonstrates compelling potential to provide a more effective
treatment or diagnosis of life-threatening or irreversibly
debilitating diseases. In addition, there must be no FDA approved
treatments presently available, or the technology must offer
significant advantages over existing approved
alternatives.
Refractory angina, resulting in continued symptoms despite
maximal medical therapy and without revascularization options, is
estimated to affect 600,000 to 1.8 million Americans, with 50,000
to 100,000 new cases per year.
About Neovasc Inc.
Neovasc is a specialty medical device company that
develops, manufactures and markets products for the rapidly growing
cardiovascular marketplace. Its products include Reducer, for the
treatment of refractory angina, which is not currently commercially
available in the United States and has been commercially available
in Europe since 2015, and Tiara(TM) for the transcatheter treatment
of mitral valve disease, which is currently under clinical
investigation in the United States, Canada, Israel and Europe. For
more information, visit: www.neovasc.com.
Investors
Mike Cavanaugh
Westwicke/ICR
Phone: +1.646.877.9641
Mike.Cavanaugh@westwicke.com
Media
Sean Leous
Westwicke/ICR
Phone: +1.646.866.4012
Sean.Leous@westwicke.com
Forward-Looking Statement
Disclaimer
Certain statements in this news release contain
forward-looking statements within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995 and applicable Canadian
securities laws that may not be based on historical fact. When used
herein, the words “expect”, “anticipate”, “estimate”, “may”,
“will”, “should”, “intend,” “believe”, and similar expressions, are
intended to identify forward-looking statements. Forward-looking
statements may involve, but are not limited to, the growing
cardiovascular marketplace. Forward-looking statements are based on
estimates and assumptions made by the Company in light of its
experience and its perception of historical trends, current
conditions and expected future developments, market and other
conditions as well as other factors that the Company believes are
appropriate in the circumstances. Many factors could cause the
Company’s actual results, performance or achievements to differ
materially from those expressed or implied by the forward-looking
statements, including those described in the “Risk Factors” section
of the Company’s Annual Report on Form 20-F and in the Management’s
Discussion and Analysis for the three and nine months ended
September 30, 2020 (copies of which may be obtained
at www.sedar.com or www.sec.gov). These factors
should be considered carefully, and readers should not place undue
reliance on the Company’s forward-looking statements. The Company
has no intention and undertakes no obligation to update or revise
any forward-looking statements, whether as a result of new
information, future events or otherwise.
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