--Successful Results from First Compassionate Use Cases
Demonstrate Feasibility and Ease of Procedure, with No Reported
Safety Issues Related to the Implantations--
NASDAQ: NVCN
TSX VENTURE: NVC
PARIS, France and VANCOUVER, Canada, May
21, 2014 /PRNewswire/ - Neovasc Inc. ("Neovasc" or the
"Company") (NASDAQ: NVCN) (TSXV: NVC), a developer of novel
technologies to treat vascular disease, reported that the first
results from early clinical experience with its Tiara™
prosthetic mitral valve were presented today at EuroPCR 2014, the
annual meeting of the European Association for Percutaneous
Cardiovascular Interventions.
The two transcatheter Tiara implantations discussed at EuroPCR
were conducted earlier this year under Special Access approvals at
St. Paul's Hospital in
Vancouver, Canada. Both resulted
in well-functioning Tiara prosthetic mitral valves without
paravalvular leak (PVL). Both procedures were straightforward and
relatively short in duration; the time taken to implant the device
in the first and second procedures was approximately 20 and 12
minutes respectively, with a total procedure time of about 1.5
hours for each case. There have been no Tiara device-related
adverse events to date.
In a session entitled "Hot line: First-in-man and novel
interventional approaches," Dr. Anson
Cheung, Professor of Surgery and Director of Cardiac
Transplant at St. Paul's Hospital,
Vancouver Canada, presented a
detailed case study of the second of the two Tiara implantations
undertaken at St. Paul's
Hospital. This case study detailed the implantation of a
Tiara valve to replace the diseased native mitral valve of a 60
year-old high-risk surgical patient with severe mitral
regurgitation (MR). The Tiara implantation was conducted via
a catheter inserted into the heart through a small incision between
the patient's ribs and was undertaken without need of cardiac
bypass or cardiac support. The implantation was quick and
uneventful, and resulted in immediate elimination of the mitral
regurgitation without PVL. The patient experienced an immediate
increase in stroke volume and decrease in pulmonary pressure.
The patient was extubated in the operating room (OR), the recovery
was uneventful and the patient was discharged home on day five
following the procedure. Echocardiographic follow-up conducted two
months post-Tiara implantation demonstrated excellent prosthetic
valve function and hemodynamics with no PVL or residual MR. At two
month follow-up, the patient demonstrated marked improvement in
symptoms compared to baseline, with a NYHA Functional Class II
(mild) rating compared to a NYHA Class III/IV (moderate/severe)
rating prior to the Tiara implantation. The New York Heart Association (NYHA) Functional
Classification is a standard method used for classifying the extent
of heart failure symptoms and places patients in one of four
categories based on their limitations in physical activity. This
patient continues to recover uneventfully three months post-Tiara
implantation with good mitral valve function, and remains in NYHA
Class II with significantly improved quality of life.
Dr. Cheung also provided an overview of their first Tiara
implantation which was completed in a 73 year-old patient with
severe MR and a range of severe co-morbidities, including poor left
ventricular function with end-stage heart failure and renal
failure, who was deemed at extremely high-risk for surgery.
This first implantation was also completed quickly and without
complications and resulted in the complete elimination of MR
without PVL. The patient experienced an immediate increase in
stroke volume and decrease in pulmonary pressure. The patient
was extubated in the OR and the initial recovery was uneventful.
Echocardiographic follow-up on this patient at two months
demonstrated excellent prosthetic valve function and hemodynamics
with no residual MR, PVL or other associated issues. This
patient died in the third month due to complications associated
with his pre-existing severe heart failure and renal disease, which
were deemed unrelated to the Tiara valve or implantation
procedure. The Tiara valve was confirmed during palliative
care to be fully functioning as intended and without complications
from the implantation.
Dr. Cheung noted that both Tiara implantations resulted in
well-functioning prosthetic mitral valves with low (<3mmHg)
transvalvular gradients and without PVL, left ventricular outflow
tract obstruction, compression of the circumflex artery, observed
thrombus or conduction abnormalities. Both procedures were
straightforward and relatively short in duration. There have been
no Tiara device related adverse events to date. It is Neovasc's
policy that if any material device related adverse events were to
occur, they would be reported in a timely manner.
Neovasc CEO Alexei Marko
commented, "We are pleased that Dr. Cheung was able to share his
initial Tiara clinical experience with physicians from around the
world in this high profile setting and we are encouraged by the
results reported to date. From this early evidence it appears
feasible that the Tiara device can be safely implanted in a short,
catheter-based procedure that can be well tolerated by these
high-risk surgical patients. Our focus is now shifting to the
design and initiation of a rigorous multicenter, multinational
clinical study for Tiara, which we hope will provide further
evidence to support the safety and feasibility of the Tiara device
and procedure. We are continuing to build our clinical team and
capabilities as we prepare to move Tiara into this next phase of
development."
About EuroPCR
EuroPCR is the annual meeting of the European Association of
Percutaneous Cardiovascular Interventions. EuroPCR 2014 is being
held in Paris, France,
May 20-23, 2014. For more
information, visit www.europcr.com.
The Tiara prosthetic mitral valve device is not
available for sale in any country.
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 the Tiara™
technology in development for the transcatheter treatment of mitral
valve disease, the Neovasc Reducer™ for the treatment of refractory
angina and a line of advanced biological tissue products that are
used as key components in third-party medical products including
transcatheter heart valves. For more information, visit
www.neovasc.com.
Statements contained herein that are not
based on historical or current fact, including without limitation
statements containing the words "anticipates," "believes," "may,"
"continues," "estimates," "expects," "forecasts", "targets", and
"will" and words of similar import, constitute "forward-looking
statements" within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995 and Canadian securities laws. Such
forward looking statements, involve known and unknown risks,
uncertainties and other factors that may cause the actual results,
events or developments to be materially different from any future
results, events or developments expressed or implied by such
forward-looking statements. Such factors include, among others, the
following: general economic and business conditions, both
nationally and in the regions in which the Company operates; the
benefits and effects of the Tiara device; history of losses and
lack of and uncertainty of revenues, ability to obtain required
financing, receipt of regulatory approval of product candidates,
ability to properly integrate newly acquired businesses, technology
changes; competition; changes in business strategy or development
plans; the ability to attract and retain qualified personnel;
existing governmental regulations and changes in, or the failure to
comply with, governmental regulations; liability and other claims
asserted against the Company; and other factors referenced in the
Company's filings with securities regulators. Although the Company
believes that expectations conveyed by the forward-looking
statements are reasonable based on the information available to it
on the date such statements were made, no assurances can be given
as to the future results, approvals or achievements. Given these
uncertainties, readers are cautioned not to place undue reliance on
such forward-looking statements. The Company does not assume the
obligation to update any forward-looking statements except as
otherwise required by applicable law.
SOURCE Neovasc Inc.
