Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today the start of enrollment in a first in-human trial of the coronary everolimus drug-coated balloon (DCB) being developed by Chansu Vascular Technologies, LLC (CVT).
The first patient was successfully treated by Dr. Irakli Gogorishvili, Head of the Interventional Cardiology Department, at the Israeli-Georgian Medical Research Clinic Helsicore in Tbilisi, Georgia. The coronary DCB was used to treat in-stent restenosis (ISR) located in the left anterior descending artery.
DCBs are a widely accepted percutaneous interventional treatment option for femoro-popliteal lesions in patients with peripheral artery disease, and are increasingly recognized for their potential in complex coronary artery disease, ISR, small vessels, and bifurcation lesions.
Everolimus, the active drug in CVT’s DCB formulation, acts as a cytostatic agent to reduce tissue hyperplasia and associated restenosis and has a long history of safety and efficacy in coronary drug-eluting stent applications.
Dr. Gogorishvili said, “The crossability and deliverability of the CVT DCB is excellent and I am very excited to participate in this research project evaluating this new class of DCBs.”
Ryan Egeland, MD, PhD, CSI’s Chief Medical Officer, said, “The CVT DCBs are designed to capitalize on the proven long-standing anti-restenotic benefits of everolimus for the treatment of patients with cardiovascular lesions. CVT intends to enroll 50 patients at up to 15 sites in France, Georgia, Lithuania and Spain to support an IDE submission to the FDA and a subsequent U.S. pivotal clinical study.”
Under the terms of the agreements signed with CVT, CSI is providing milestone-based financing to CVT for the development of coronary and peripheral DCBs. Under an acquisition option agreement, upon CVT’s completion of key technical and clinical milestones in the development program, CSI will have exclusive rights and obligations to acquire CVT, subject to the satisfaction of closing conditions set forth in the agreement.