CSII - CSII announces enrollment in trial of Everolimus Drug-Coated Balloon for artery disease
Cardiovascular Systems (NASDAQ:CSII) said enrollment has begun in a first in-human trial of peripheral everolimus drug-coated balloon (DCB) being developed by Chansu Vascular Technologies. The company said DCBs are a widely accepted percutaneous interventional treatment option for femoro-popliteal lesions in patients with peripheral artery disease. Everolimus, the active drug in Chansu DCB formulation, acts as agent to reduce tissue growth and associated restenosis. Peripheral arterial disease in the legs or lower extremities is the narrowing or blockage of the vessels which carry blood from the heart to the legs. Chansu intends to enroll 75 patients at a minimum of four sites in France and Germany to support an IDE submission to the FDA and a subsequent U.S. pivotal clinical study. Under the terms of agreements signed with Chansu, CSII is providing milestone-based financing to Chansu for the development of coronary and peripheral DCBs. Under an acquisition option agreement, upon Chansu's completion of key
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CSII announces enrollment in trial of Everolimus Drug-Coated Balloon for artery disease