February 03, 2014 9:16am EST
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK), a multi-national biopharmaceutical and
diagnostics company, today reported that Neovasc Inc. (TSXV:NVC), a
Vancouver-based company in which OPKO has made a strategic investment,
reported that a first-in-human implantation of its Tiara™ transcatheter
mitral valve was successfully performed on January 30th by physicians at
St. Paul’s Hospital in Vancouver, BC. The transapical procedure resulted
in the elimination of mitral regurgitation (MR) and significantly
improved heart function in the patient, without the need for cardiac
bypass support and with no procedural complications.
The implantation was conducted by Dr. Anson Cheung, Professor of Surgery
and Director of Cardiac Transplant, and Dr. John Webb, Director of
Interventional Cardiology, at St. Paul’s Hospital. They were supported
by Dr. Stefan Verheye, Senior Interventional Cardiologist at the Antwerp
Cardiovascular Center / ZNA Middelheim, Belgium and Dr. Shmuel Banai,
Medical Director of Neovasc and Director of Interventional Cardiology at
Tel Aviv Medical Center, Israel.
Commenting on the procedure, Dr. Cheung stated, “This 73 year-old male
patient had severe functional mitral regurgitation and was considered an
extremely high risk candidate for conventional valve repair or
replacement surgery. The transapical implantation of the Tiara valve was
completed quickly and without complications. It resulted in a
well-functioning bioprosthetic valve with no significant paravalvular
leak or residual MR.”
Dr. Cheung added, “We are very pleased that this first implantation went
so smoothly and that the patient’s outcome to date is so positive. His
recovery has been uneventful, and we will continue to follow him closely
over the coming months. The ability to implant a prosthetic mitral heart
valve using a transcatheter, minimally-invasive approach instead of
conventional open chest, open heart surgery would provide a much-needed
alternative for the many patients who are considered at high risk for
conventional surgery.”
Tiara is a self-expanding mitral bioprosthesis specifically designed to
treat mitral valve regurgitation, a serious and poorly served condition
that requires development of highly specialized devices to address the
complex mitral anatomy. Significant mitral regurgitation can lead to
heart failure and death. Conventional surgical treatments are only
appropriate for about half of the estimated four million MR patients in
the US alone.
Tiara is implanted in the heart using a minimally-invasive,
transcatheter approach and is designed to replace the diseased native
mitral valve without the need for open heart surgery or use of a cardiac
bypass machine.
About Neovasc Inc.
Neovasc Inc. is a specialty medical device company that develops,
manufactures and markets products for the rapidly growing global
cardiovascular marketplace. Its products include the Neovasc Reducer™
for the treatment of refractory angina and the Tiara™ transcatheter
mitral value replacement device in development for the treatment of
mitral regurgitation. In addition, Neovasc's advanced biological tissue
products are widely used as key components in a variety of third-party
medical products, such as transcatheter heart valves. For more
information, visit: www.neovasc.com .
About OPKO Health, Inc.
We are a multi-national biopharmaceutical and diagnostics company that
seeks to establish industry-leading positions in large and rapidly
growing medical markets by leveraging our discovery, development and
commercialization expertise and our novel and proprietary technologies.
This press release contains "forward-looking statements," as that
term is defined under the Private Securities Litigation Reform Act of
1995 (PSLRA), which statements may be identified by words such as
"expects," "plans," "projects," "will," "may," "anticipates,"
"believes," "should," "intends," "estimates," and other words of similar
meaning, including statements regarding expected benefits of the Tiara™
transcatheter mitral value replacement device, whether the device will
be successful in treating mitral valve regurgitation, and whether the
device will be commercialized at all, as well as other non-historical
statements about our expectations, beliefs or intentions regarding
business, technologies and products, financial condition, strategies or
prospects. Many factors could cause actual activities or results to
differ materially from the activities and results anticipated in
forward-looking statements. These factors include those described in our
filings with the Securities and Exchange Commission, as well as the
risks inherent in funding, developing and obtaining regulatory approvals
of new, commercially-viable and competitive products and treatments,
that earlier clinical results of effectiveness and safety may not be
reproducible or indicative of future results, that compounds or
diagnostic products under development may fail, may not achieve the
expected results or effectiveness and may not generate data that would
support the approval or marketing of products for the indications being
studied or for other indications, that currently available
over-the-counter and prescription products, as well as products under
development by others, may prove to be as or more effective than our
products for the indications being studied. In addition, forward-looking
statements may also be adversely affected by general market factors,
competitive product development, product availability, federal and state
regulations and legislation, the regulatory process for new products and
indications, manufacturing issues that may arise, patent positions and
litigation, among other factors. The forward-looking statements
contained in this press release speak only as of the date the statements
were made, and we do not undertake any obligation to update
forward-looking statements. We intend that all forward-looking
statements be subject to the safe-harbor provisions of the PSLRA.
OPKO Health, Inc.
Steven D. Rubin or Juan F. Rodriguez,
Source: OPKO Health, Inc.
Released February 3, 2014
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