- Neovasc (NVCN) has received approval from the U.S. Food and Drug Administration (FDA) for the Investigational Device Exemption regarding its COSIRA-II IDE Clinical Trial
- The approval of the supplement is in line with Neovasc’s internal target, and the Company remains on track to enrol the first patient in the trial late this year
- COSIRA-II is a randomized, sham-controlled trial investigating the safety and effectiveness of the Neovasc Reducer for patients with refractory angina
- The Reducer is for the treatment of refractory angina, a painful and debilitating condition
- Neovasc is up 4.3 per cent, trading at $0.97 at 1:12 pm ET
Neovasc (NVCN) has received approval from the FDA for the Investigational Device Exemption regarding its COSIRA-II IDE Clinical Trial.
The approval of the supplement is in line with Neovasc’s internal target, and the Company remains on track to enroll the first patient in the trial late this year.
The approved protocol for the COSIRA-II study is designed to answer questions arising from the October 2020 Circulatory Systems Devices Panel Meeting regarding the Neovasc Reducer.
COSIRA-II is a randomized, sham-controlled trial investigating the safety and effectiveness of the company’s Reducer for patients suffering from refractory angina.
“FDA approval of the IDE Supplement is another important milestone for Neovasc. We are grateful for the collaborative work with FDA and we are pleased that our study initiation remains on track.” She continued, “Refractory angina is a debilitating condition, and we are excited to offer patients in the US and Canada a clinical trial with a treatment option that may alleviate their suffering,” said Neovasc Vice President of Regulatory Affairs, Global Angina Therapies Lisa Becker.
The Reducer is CE-marked in the European Union and Under Investigation in the United States 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, despite treatment with standard revascularization or cardiac drug therapies.
Neovasc is up 4.3 per cent, trading at $0.97 at 1:12 pm ET.