HOPE IS ON THE HORIZON
COSIRA-II Clinical Trial Underway
COSIRA-II (COronary SInus Reducer for the Treatment of Refractory Angina) is a clinical trial designed to evaluate the safety and effectiveness of the Neovasc Reducer™ device in treating patients suffering from refractory angina.
Refractory angina – long-lasting, debilitating chest pain that cannot be controlled by traditional medicine or surgical procedures – affects millions of people world-wide.
In the U.S., the Reducer device is currently approved for ‘Investigational Use Only’ which means that at this time, only select patients can get this treatment by participating in the COSIRA-II clinical trial. Because this study uses scientific methodologies to determine effectiveness, not all patients who participate in COSIRA-II will receive the treatment.
Talk to your doctor about whether the COSIRA-II trial is right for you.
COSIRA-II FREQUENTLY ASKED QUESTIONS
U.S. patients with chronic refractory angina who are not candidates for further revascularization surgery may be eligible for this trial. Certain medical criteria must be met before enrolling in the COSIRA-II clinical trial. Eligibility information and locations can be found here>
Speak to your doctor or health care provider to see if participating in the COSIRA-II trial is right for you.
What is the COSIRA-II clinical trial?
COSIRA-II (COronary SInus Reducer for the Treatment of Refractory Angina) is a clinical trial designed to evaluate the safety and effectiveness of the Neovasc Reducer™* device in treating patients suffering from refractory angina. Refractory angina – long-lasting, debilitating chest pain that cannot being controlled by traditional medicine or surgical procedures – effects millions of people world-wide. In the U.S., the Reducer is currently approved for ‘Investigational Use Only’ which means that at this time, only select patients can receive this treatment by participating in the COSIRA-II clinical trial.
Talk to your doctor about whether participating in the COSIRA-II trial is right for you.
Is this clinical trial happening near me?
Medical Centers throughout North America are currently being evaluated and as they sign on location and contact information will be available here>
What are the benefits of participating?
COSIRA-II is an opportunity for selected patients to receive this novel treatment for refractory angina before it is approved in the U.S. Participation also provides data that can improve the health of a much larger population of patients.
How do I enroll in the trial?
U.S. patients with chronic refractory angina who are not candidates for further revascularization surgery may be eligible for this trial. Certain medical criteria must be met before enrolling in the COSIRA-II clinical trial. Eligibility and exclusionary criteria for this trial can be found here >
Talk to your doctor to see if this trial is right for you.
Who is eligible to participate?
COSIRA-II is for patients, 18 years old and up, with chronic refractory angina despite receiving optimal medical therapy and who are not candidates for revascularization surgery. Certain medical criteria must be met before enrolling in a clinical trial. Eligibility and exclusionary criteria for COSIRA-II can be found here>
Talk to your doctor to determine if this trial is right for you.
How is the procedure performed?
Implantation of the Neovasc Reducer* is usually performed under local anesthesia using a catheter inserted through a small needle puncture in the jugular vein. Patients are typically discharged within 24 hours.
Watch an animation of the procedure here >.
Have patients already been treated with Reducer*?
Reducer* has been approved in many other countries around the world, but has not been approved for use in the United States. To date, over 2,000 patients have had the Reducer device implanted. Neovasc hopes COSIRA-II will provide the necessary data for the Food & Drug Administration (FDA) to approve the device to treat patients in the United States.
What should I expect after the procedure?
Relief varies by patient and depends on a number of factors. Many patients who have had Reducer implanted report relief from angina symptoms sometimes as early as 6 weeks after the procedure, with most patients reporting improvement within 3 months.
Clinicians will monitor your condition on an on-going basis. Ask your doctor for more details.
*Reducer is not available in every geography. For investigational use only in the United States.
Important safety information may be found here>
WHAT IS REFRACTORY ANGINA?
Angina is a type of chest pain, usually a symptom of coronary artery disease (CAD). CAD happens when plaque build-up occurs in the arteries supplying oxygen-rich blood to the heart, forcing the heart to work harder. This is what produces the painful angina, which may feel like pressure or squeezing in the chest, or pain in the shoulders, arms, neck, jaw or back.
Of all patients experiencing angina, it is estimated that about 10%¹ suffer symptoms that are severe, long lasting, and cannot be controlled by traditional medical therapies. This severely debilitating condition is known as refractory angina.
¹Guglielmo Gallone, MD, Luca Baldetti, MD, Georgios Tzanis, MD, Mario Gramegna, MD, Azeem Latib, MD, Antonio Colombo, MD, Timothy D. Henry, MD, Francesco Giannini, MD Refractory Angina From Pathophysiology to New Therapeutic Nonpharmacological Technologies JACC: CARDIOVASCULAR INTERVENTIONS CME/MOC/ECME
NEOVASC REDUCER™
Prior to the Reducer System there were few, if any, real options for treating chronic refractory angina.
The Reducer* is a small, hourglass shaped device implanted in the coronary sinus, a collection of veins joined together to form a large vessel that collects blood from the heart muscle. The device creates back pressure within the coronary sinus that increases the flow of oxygen-rich blood to areas of the heart that previously did not have normal blood flow.
The Reducer Device is approved for use in many countries and has been successfully implanted in thousands of patients internationally. The long-term results of Reducer therapy continue to be studied. As with any medical procedure, there are risks associated with the use of the Neovasc Reducer. For a complete list of potential risks and benefits, ask your doctor.
Doctors place the device using a minimally invasive procedure, usually performed under local anesthesia. Most patients are discharged within 24 hours. Relief varies by patient and depends on a number of factors, but some patients report relief from angina symptoms as early as six weeks after the procedure, with most patients reporting improvement within three months.
*Reducer is not available in every geography. Investigational use only in the United States.
Important safety information may be found here>
PATIENT TESTIMONIAL
JEAN’S STORY
Jean, an active 80-year-old Londoner, had started becoming depressed as severe and increasingly untreatable angina negatively affected her quality of life. Her doctor recommended Reducer* therapy, which helped Jean get her life back.
“If I want to go out, it doesn’t take me half an hour to get out of the house…my life is a lot more social now, and that stops you from being depressed… I’m just glad I had it done and I would advise everybody else that has bad angina, if they’re offered (Reducer Therapy), take it.”
– Jean, Reducer Patient
*Reducer is not available in every geography. For investigational use only in the United States.