CSI Announces FIH Procedure With Chansu’s Coronary DCB

November 4, 2021—Cardiovascular Systems, Inc. (CSI) announced the start of enrollment in a first-in-human trial of a coronary everolimus drug-coated balloon (DCB) being developed by Chansu Vascular Technologies, LLC (CVT).

The first patient was successfully treated for in-stent restenosis located in the left anterior descending artery. The procedure was performed by Irakli Gogorishvili, MD, Head of the Interventional Cardiology Department at the Israeli-Georgian Medical Research Clinic Helsicore in Tbilisi, Georgia.

“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,” commented Dr. Gogorishvili in CSI’s press release.

Ryan Egeland, MD, CSI’s Chief Medical Officer, added, “The CVT DCBs are designed to capitalize on the proven long-standing antirestenotic benefits of everolimus for the treatment of patients with cardiovascular lesions.”

Dr. Egeland further advised, “CVT intends to enroll 50 patients at up to 15 sites in France, Georgia, Lithuania, and Spain to support an investigational device exemption submission to the FDA and a subsequent United States pivotal clinical study.”

According to the company, 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.

CVT, which was founded by Philippe Marco, MD, is based in Sunnyvale, California. CSI is headquartered in St. Paul, Minnesota.