- Neovasc receives FDA approval for protocol supplement to the COSIRA-II IDE Trial.
- Single arm registry to allow inclusion of additional specified patient populations
- The approval expands the number of patients eligible for treatment in the trial
- “FDA approval of this IDE Supplement is another important milestone for Neovasc and for patients suffering from angina”
- There are over two-million angiograms performed each year in the U.S. alone
- Neovasc (NVCN) is down 0.33 per cent trading at C$8.47 as of 1:30 pm EDT
Neovasc (NVCN) has announced the U.S. Food and Drug Administration (FDA) has approved a protocol supplement to the COSIRA-II Investigational Device Exemption (IDE) Trial.
The approval expands the number of patients eligible for treatment in the trial. It adds two previously planned imaging sub-studies designed to provide insights into the safety and mechanism of action of the Neovasc Reducer (Reducer).
The timing of the approval is ahead of the company’s internal target and will allow for additional patients to be treated.
The newly-approved supplement adds a single, non-randomized arm to the existing protocol that allows enrollment of patients who are believed to benefit from Reducer implantation to reduce their angina symptoms but who do not otherwise qualify for the randomized arm.
These patients are well defined within the protocol and include patients with non-obstructive coronary artery disease who were previously ineligible for treatment. In addition, the expansion allows patients with predominantly right-sided ischemia and those unable to perform a treadmill test due to amputation to be included.
There are over two-million angiograms performed per year in the U. S., most of which are performed on patients with angina.
Nearly 40 per cent of patients receiving angiograms do not have obstructive coronary artery disease. While approximately 35 per cent of patients with obstructive coronary disease are women, the percentage of patients with non-obstructive disease that are women approaches 55 per cent.
The company says the “newly-added arm in the COSIRA-II study provides an opportunity to study the Reducer in the non-obstructive population.”
National Co-principal Investigator, Tim Henry, M.D. of Christ Hospital in Cincinnati Ohio, commented,
“Today’s news is a big win for patients suffering from refractory angina. I’m pleased that these specific patients previously ineligible for the Trial will now be able to be treated with the Reducer. The PET and CT sub-studies will give us important insights into the mechanism of action and safety of the Reducer, and the addition of patients with non-obstructive coronary disease will enable us to treat a much broader patient population.”
Lisa Becker, Neovasc Vice President of Regulatory Affairs, added,
“FDA approval of this IDE Supplement is another important milestone for Neovasc and for patients suffering from angina. We are particularly encouraged to investigate the Reducer in a population that disproportionately affects women. We appreciate the collaboration and rigor of FDA in the advancement of this important addition to the COSIRA-II trial.”
Neovasc is a specialty medical device company that develops and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina – which is not currently commercially available in the U.S.
Reducer has been commercially available in Europe since 2015, and Tiara for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the U.S., Canada, Israel, and Europe.
Neovasc Inc. (NVCN) is down 0.33 per cent trading at C$8.47 as of 1:30 pm EDT.