Cardiovascular Systems has announced the start of enrolment in a first in-human trial of the coronary everolimus drug-coated balloon (DCB) being developed by Chansu Vascular Technologies.
The first patient was successfully treated by Irakli Gogorishvili, head of the Interventional Cardiology Department, Israeli-Georgian Medical Research Clinic Helsicore, 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 recognised for their potential in complex coronary artery disease, ISR, small vessels, and bifurcation lesions.
Everolimus, the active drug in Chansu Vascular Technologies’ 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.
Gogorishvili said: “The crossability and deliverability of the Chansu Vascular Technologies DCB is excellent and I am very excited to participate in this research project evaluating this new class of DCBs.”
Ryan Egeland, Cardiovascular System’s chief medical officer, said: “The Chansu Vascular Technologies DCBs are designed to capitalise on the proven long-standing anti-restenotic benefits of everolimus for the treatment of patients with cardiovascular lesions. Chansu Vascular Technologies 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 Chansu Vascular Technologies, Cardiovascular Systems is providing milestone-based financing to Chansu Vascular Technologies for the development of coronary and peripheral DCBs. Under an acquisition option agreement, upon Chansu Vascular Technologies’ completion of key technical and clinical milestones in the development program, Cardiovascular Systems will have exclusive rights and obligations to acquire Chansu Vascular Technologies, subject to the satisfaction of closing conditions set forth in the agreement.