Cardiovascular Systems Inc (CSI) has announced the start of enrolment in a first in-human trial of the peripheral everolimus drug-coated balloon (DCB) being developed by Chansu Vascular Technologies (CVT).
DCBs are a widely accepted percutaneous interventional treatment option for femoropopliteal lesions in patients with peripheral arterial disease. 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.
The first patient was treated by Benjamin Honton, principal investigator at the Clinique Pasteur, Toulouse, France. The peripheral DCB was used to successfully treat a 69-year-old male with a 7.5cm lesion in his superficial femoral artery (SFA).
“We are honoured to enrol the first patient in the CVT-SFA trial,” said Honton. “We believe this promising new generation of everolimus DCBs could improve patient outcomes for those suffering from peripheral arterial disease.”
CVT intends to enrol 75 patients at a minimum of four sites in France and Germany to support an investigational device exemption (IDE) submission to the US Food and Drug Administration (FDA) and a subsequent US pivotal clinical study.
Jeffery Chambers, CSI’s chief medical officer, said: “Following the announcement of the first in-human experience with CVT’s coronary everolimus DCB in November 2021, we are thrilled to announce the first in-human experience with the peripheral everolimus DCB. We believe these products could become important new therapies in the treatment of peripheral and coronary artery disease.”
Under the terms of the agreements signed with CVT, CSI advises that it 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 programme, CSI will have exclusive rights and obligations to acquire CVT, subject to the satisfaction of closing conditions set forth in the agreement.