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Neovasc Reducer™ for Refractory Angina -
Patient Enrollment Begins in Montreal
Neovasc Press Releases
A North American first at the Montreal Heart Institute could help treat thousands of Canadians
Successful initiation of trial for new device designed to treat patients who suffer from refractory angina
Montreal, February 23, 2011 – The interventional cardiology team at the Montreal Heart
Institute (MHI) recently began patient enrollment for a new device, the Neovasc Reducer™,
designed to treat patients suffering from refractory angina. The treatment method is a first in
North America and is being conducted as part of an international study, the COSIRA trial. This
innovative treatment is promising for thousands of Canadians disabled by refractory angina and
who lack alternatives for relieving their symptoms and improving their quality of life.
Developed in Canada by Neovasc Inc. (TSX Venture: NVC), the Reducer is implanted in the
coronary sinus vein using minimally invasive techniques. Placement of the device is performed
using a procedure that is similar to implanting a coronary stent and takes approximately 20
minutes. The Reducer is designed to establish a permanent and controlled narrowing of the
coronary sinus, which is a new technique to provide relief of refractory angina symptoms by
altering blood flow in the coronary sinus and thereby increasing perfusion of oxygenated blood
to certain areas of the heart muscle that receive an inadequate supply of oxygen. Patients are
discharged within 24 hours after the intervention.
This landmark procedure was carried out by a MHI multidisciplinary team composed of Drs.
Marc Jolicoeur, Serge Doucet and Jean-François Tanguay, interventional cardiologists, as well as
Dr. Raymond Cartier, heart surgeon. “All the initial cases have gone very well and we are
optimistic that the long term results of the procedure will be favourable” says Dr. Marc Jolicoeur
who is also assistant professor in the faculty of medicine at the Université de Montréal. “This
new method to treat refractory angina safely provides care for patients who cannot be helped
with conventional drug, catheter or surgical therapy.”
The COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) trial is a multicenter,
sham-controlled, randomized, double-blinded study of the Reducer that is expected to enroll up
to 124 patients. The primary endpoint is efficacy in reducing angina symptoms after six months.
In addition to the Montreal Heart Institute, the COSIRA trial is also enrolling patients at the
University of Ottawa Heart Institute, the Antwerp Cardiovascular Institute and Ziekenhuis Oost-
Linburg Hospital in Belgium; and Ultrecht Medical Center in the Netherlands. Additional sites
are expected to join the trial in the coming months.
Results from the initial first-in-man clinical trial of the Reducer were presented at the American
College of Cardiology 2010 annual meeting. The data showed that three years after implantation
of the Reducer, the product remained safe and the majority of the 15 patients treated continued
to show measurable improvement in angina symptoms.
About refractory angina
Refractory angina is a painful and debilitating condition that occurs when the coronary arteries
deliver an inadequate supply of blood to the heart muscle. It currently affects over two million
patients worldwide, who typically lead severely restricted lives and current treatment options
are limited. The incidence of refractory angina is currently growing as better treatments for
coronary artery disease reduce mortality and increase number of patients with advanced
disease.
About the Montreal Heart Institute
Founded in 1954 by Dr. Paul David, the Montreal Heart Institute constantly aims for the highest
standards of excellence in the cardiovascular field through its leadership in
prevention, ultra-specialized care, training of professionals, clinical and fundamental research,
and assessment of new technologies. It is affiliated with the Université de Montréal and its
clinical outcomes are among the best in the world.
To learn more about the Institute, please visit our website at www.icm-mhi.org.
About Neovasc Inc.
Neovasc Inc. is a specialty vascular device company that develops, manufactures and markets
medical devices for the rapidly growing vascular and surgical marketplace. Current products
include the Neovasc Reducer™, a novel product in development to treat refractory angina, and a
line of advanced biological tissue technologies that are used to enhance surgical outcomes and
as key components in a variety of third-party medical products, including transcatheter heart
valves.
For more information, visit: www.neovasc.com
Information: Julie Chevrette
Communications Officer
Montreal Heart Institute
514 376-3330, ext. 2641
julie.chevrette@icm-mhi.org
Featured Angina| Acute Coronary Syndrome and Heart Disease Interviews
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Highlights of Article by Dr. Erik Hess et of Mayo Clinic ;CIRCOUTCOMES 2012
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Chest pain is the 2nd most common reason patients come to EDs across the United States
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Initial testing – including information obtained from the history, physical exam, electrocardiogram, and cardiac troponin – identifies > 98% of heart attacks
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To avoid missing a diagnosis of heart attack or pre-heart attack symptoms, emergency physicians often admit patients to observation units or to the hospital for extensive diagnostic testing, including stress testing
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This results in false positive test results, unnecessary exposure to radiation, and unnecessary downstream procedures such as stent placement in arteries of the heart
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Decision aids are evidence-based tools designed to educate and engage patients in decisions regarding their care
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We hypothesized that patients who were educated regarding their future risk for a heart attack and engaged in the decision of whether to be admitted to the observation unit for stress testing or to follow-up with a Mayo Clinic heart doctor in the next 72 hours would have greater knowledge about their short-term risk for heart attack, be more aware of the management options, and choose less intensive approaches to evaluation
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We randomly assigned 204 patients who came to the ED with chest pain and were being considered for observation unit admission to the decision aid or to usual care
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Decision aid patients:
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Had greater knowledge regarding their short-term risk for a heart attack
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Less frequently decided to be admitted to the observation unit for stress testing
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Had 4 times greater engagement in the decision making process
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Had no adverse events within 30 days of the ED visit
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Take home points
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Patients want to be educated and engaged in decisions regarding their care
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Once properly informed and engaged in treatment decisions, patients often choose less intensive treatment options
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Integrated health systems like the Mayo Clinic in which physicians collaboratively work together to provide ER patients ready access to outpatient follow-up have potential to improve the value of Emergency care
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Glucose, Insulin and Potassium (“GIK”) TO MINIMIZE IMPACT OF HEART ATTACKS BEFORE PATIENTS GET TO THE HOSPITAL
Study puts life-saving drugs in the hands of paramedics, decreasing rate of cardiac arrest and death from heart attacks
CHICAGO (March 27, 2012) — Paramedics can potentially reduce someone’s chances of having a cardiac arrest or dying by 50 percent by immediately administering a mixture of glucose, insulin and potassium (“GIK”) to people having a heart attack, according to research presented today at the American College of Cardiology’s 61st Annual Scientific Session. The Scientific Session, the premier cardiovascular medical meeting, brings cardiovascular professionals together to further advances in the field.
The study showed that patients who received GIK immediately after being diagnosed with acute coronary syndrome — which indicates a possible heart attack is either in progress or on the way — were 50 percent less likely to have cardiac arrest (a condition in which the heart suddenly stops beating) or die than those who received a placebo, although the treatment did not prevent the heart attack from occurring. The reduction in in-hospital cardiac arrest or death was a “secondary endpoint”, so statistically was not definitive, but was consistent with how GIK seems to work in experimental models of heart attack.
The effect was also present for patients with ST-elevation heart attacks, which require immediate treatment. For those patients, immediate GIK was associated with a 60 percent reduction in in-hospital cardiac arrest or death.
“When started immediately in the home or on the way to the hospital — even before the diagnosis is completely established — GIK appears not completely prevent any heart attack from occurring, but appeared in this trial to reduce the size of heart attacks and to reduce by half the risk of having a cardiac arrest or dying,” said Harry P. Selker, MD, MSPH, executive director of the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center, who led the study with Joni Beshansky, RN, MPH, co-principal investigator and project director. “Acute coronary syndromes represent the largest cause of death in this country. GIK is a very inexpensive treatment that appears to have promise in reducing those deaths and morbidity.”
The cost of the treatment is about $50.
“Because the trial is the first to show GIK could be effective when used by paramedics in real-world community settings, it could have important implications for the treatment of heart attacks,” Dr. Selker said. Previous clinical trials have shown no consistent effect, likely because the GIK was given too late to help. This study, the “IMMEDIATE Trial,” was the first to test the effectiveness of administering GIK at the very first signs of a threatening heart attack, in the community, rather than waiting hours until the diagnosis was well-established at a hospital, as done in previous clinical trials.
“We wanted to do something that is effective and can be used anywhere,” said Dr. Selker. “We’ve done a lot of studies of acute cardiac care in emergency departments and hospitals, but more people die of heart attacks outside the hospital than inside the hospital. Hundreds of thousands of people per year are dying out in the community; we wanted to direct our attention to those patients.”
The researchers trained paramedics in 36 Emergency Medical Services systems in 13 cities across the country to administer GIK after determining that a patient was likely having a threatened or already established heart attack using electrocardiograph-based ACI-TIPI (acute cardiac ischemia time-insensitive predictive instrument) and thrombolytic predictive instrument decision support that prints patient-specific predictions on the top of an electrocardiogram. The paramedics used these predictions to decide if a patient would likely benefit from treatment. There were 911 patients randomized to receive either the GIK treatment or a placebo.
Administering GIK immediately also reduced the severity of the damage to the heart tissue from the heart attack. On average, 2 percent of the heart tissue was destroyed by the heart attack in people receiving GIK, compared with 10 percent in those who received the placebo. Although a significant proportion of suspected heart attacks are later determined to be false alarms (23 percent in this study), administering GIK does not appear to cause any harmful effects in such patients.
The research team will follow up with study participants at six and 12 months to evaluate the longer-term benefit of the GIK treatment.
This study was funded by the NIH’s National Heart, Lung and Blood Institute.
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Keywords and tags:
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Angina | Heart Disease Resourses
| Chest Pain
Amazon.com 's Editorial Reviews
Angina: New Ways to Treat
Chronic Chest Pain
Part of the award winning public television series Healthy head
/Healthy Mind. It's one of the scariest medical symptoms for people who are generally healthy: a tightening, painful feeling in the chest known as Angina. In some cases this chest pain can be a serious warning that requires immediate treatment. But for the millions of people with chronic, stable angina the discomfort is something that can be readily managed with a variety of treatments. In this program we take a look at what generally causes angina, what can be done to prevent it and how it can be effectively treated with lifestyle changes, innovative drug therapies and medical procedures.
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Amazon.com Editorial Review:
Philips HeartStart Home Defibrillator (AED)
Be prepared for the unexpected.
When sudden cardiac arrest (SCA) strikes, the electrical system of the heart short circuits, causing the heart to quiver rather than pump in a normal rhythm. It typically results in the abnormal heart rhythm know as ventricular fibrillation (VF). It usually happens without warning and the majority of people have no previously recognized symptoms of heart disease. And it most often happens at home. For the best chance of survival from SCA caused by VF, a defibrillator should be used within 5 minutes. Yet, less than 1 in 20 people survive largely because a defibrillator does not arrive in time.
Just as seat belts or airbags do not save every life in a traffic accident, a defibrillator will not save every person who suffers a sudden cardiac arrest. Yet many lives could be saved if more people could be reached more quickly.
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