November 14, 2011 – Vancouver,
BC, Canada
– Neovasc Inc. (TSXV: NVC), today announced that it has received the CE mark
designation for its Reducer™ product for the treatment of refractory angina. CE
marking confirms that the Reducer conforms to the applicable European Directive
and allows the product to be marketed for implantation in patients in all
member states of the European Union, the European Economic Area and Switzerland.
The Neovasc Reducer is a novel device designed to treat the
millions of patients worldwide who suffer from refractory angina, a painful and
debilitating condition that occurs when the coronary arteries deliver an
inadequate supply of blood to the heart muscle. Refractory angina currently
affects an estimated one million patients in Europe,
who often lead severely restricted lives. The incidence of refractory angina is
growing, yet current treatment options are limited.
Christopher White, MD, professor of medicine and system
chair for cardiovascular diseases, the Ochsner Clinical School, University of
Queensland, and medical director, John Ochsner Heart & Vascular Institute,
Ochsner Medical Center, commented, “The Reducer appears to be a very promising
tool for treating patients with the disabling ischemic chest pain known as
angina. Achieving the European CE mark will allow this technology to be used in
‘real world patients and sets the stage for much needed clinical trials in the
US.”
The Reducer is implanted in the coronary sinus vein using
minimally invasive techniques that are similar to implanting a coronary stent. By
modulating blood flow from the coronary sinus-the main vein exiting the
heart-the Reducer acts to increase the perfusion of oxygenated blood to certain
areas of the heart muscle, thereby reducing the pain and disability caused by
the condition.
“The Reducers CE mark designation is good news for European
refractory angina patients, who previously had exhausted available treatment
options but who will now have access to this novel treatment for relieving
their symptoms and improving their quality of life,” said Dr. Shmuel Banai,
medical director of Neovasc. “In addition, the Reducer is implanted using a
procedure that is minimally invasive and requires less than 20 minutes to
complete.”
Results of a published prospective three-year clinical study
have demonstrated that the Reducer is safe and effective at providing relief of
angina symptoms in refractory angina patients. Neovasc is presently enrolling
patients in the COSIRA (Coronary Sinus Reducer for Treatment of Refractory
Angina) trial, a multicenter, sham-controlled, randomized, double-blinded
study. COSIRA has been designed to provide additional controlled, statistically
significant data to further demonstrate the clinical efficacy of the Reducer
and to support physician education and marketing efforts. It will also support
additional regulatory applications to make the Reducer available to the
millions of refractory angina patients worldwide who could potentially benefit.
“We are very pleased to have received CE mark designation to
treat this critical patient population with high unmet need,” noted Alexei
Marko, CEO of Neovasc. “In the immediate term we will continue to focus on completing
enrollment in the COSIRA trial in order to obtain additional data that we
expect will be very valuable in supporting medical education and marketing
activities for the Reducer. We are currently evaluating a number of options for
European commercialization and look forward to distributing the Reducer in
select European markets beginning in 2012.”
About the Neovasc Reducer™
The Reducer has received a CE mark designation in Europe
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. Refractory angina currently affects over two million patients
worldwide, who typically experience severe chest pain from even minor physical
exertion and as a result lead restricted lives. The incidence of refractory
angina is growing, yet these patients have largely exhausted available
treatment options. The Reducer is intended to provide relief of refractory
angina symptoms by altering blood flow in the coronary sinus vein and thereby
increasing perfusion of oxygenated blood to certain areas of the heart muscle
that receive an inadequate supply of oxygen. Placement of the Reducer is
performed using a minimally invasive percutaneous procedure that is similar to
implanting a coronary stent and takes 20 minutes or less.
Long-term results from a prospective clinical trial of the
Reducer presented at the American College of Cardiology 2010 annual meeting
confirmed positive initial data that had previously been reported in the Journal
of the American College of Cardiology*. The long-term data showed that the
Neovasc Reducer continued to demonstrate an excellent safety profile and that
the objective and subjective improvement in angina scores and ischemia
parameters seen after six months were maintained for the entire three-year
follow-up period. There were no reported deaths, myocardial infarctions,
strokes or other adverse events attributed to the device. Neovasc is presently
enrolling patients in the COSIRA trial, a multicenter, sham-controlled,
randomized, double-blinded study designed to further demonstrate the efficacy
of the Reducer product and to support additional regulatory applications.
*Banai S, Ben Muvhar S, Parikh KH, et. al. Coronary Sinus
Reducer Stent for the Treatment of Chronic Refractory Angina Pectoris. J Am
Coll Cardiol 2007;49: 1783-9
About Neovasc Inc.
Neovasc Inc. is a specialty medical device company that develops, manufactures
and markets products for the rapidly growing cardiovascular marketplace. Its
products include the Neovasc Reducer™ for the treatment of refractory angina,
the Tiara™ technology in development for the transcatheter treatment of mitral
valve disease and a line of advanced biological tissue products that are used
as key components in a variety of third-party medical products, such as
vascular surgical patches and transcatheter heart valves. For more information,
visit: www.neovasc.com.