CSI Begins FIH Trial of Chansu Vascular’s Peripheral Everolimus DCB

March 9, 2022—Cardiovascular Systems, Inc. (CSI) announced today the start of enrollment in a first-in-human (FIH) trial of the peripheral everolimus drug-coated balloon (DCB) being developed by Chansu Vascular Technologies, LLC (CVT).

According to CSI, CVT intends to enroll 75 patients at a minimum of four sites in France and Germany. The trial will support an investigational device exemption submission to the FDA and a subsequent United States pivotal clinical study.

The first patient was treated by Benjamin Honton, MD, Principal Investigator at the Clinique Pasteur, Toulouse, France. Dr. Honton used the peripheral DCB to successfully treat a male, age 69 years, with a 7.5-cm lesion in his superficial femoral artery (SFA).

“We are honored to enroll the first patient in the CVT-SFA trial,” commented Dr. Honton in CSI’s press release. “We believe this promising new generation of everolimus DCBs could improve patient outcomes for those suffering from peripheral artery disease.”

On February 1, 2021, CSI announced that it partnered with CVT to develop novel peripheral and coronary everolimus DCBs.

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. Additionally, an acquisition option agreement provides CSI exclusive rights and obligations to acquire CVT upon CVT’s completion of key technical and clinical milestones in the development program. The option is subject to the satisfaction of closing conditions set forth in the agreement.

Jeffery Chambers, MD, CSI’s Chief Medical Officer, added, “Following the announcement of the FIH experience with CVT’s coronary everolimus DCB in November 2021, we are thrilled to announce the FIH experience with the peripheral everolimus DCB. We believe these products could become important new therapies in the treatment of peripheral and coronary artery disease.”