Cardiovascular Systems Treats First Patient in Everolimus Balloon Study

Cardiovascular Systems Inc. (CSI) has begun enrolling patients in a first in-human trial of the peripheral everolimus drug-coated balloon (DCB) being developed by Chansu Vascular Technologies LLC (CVT).
 
DCBs are a widely accepted percutaneous interventional treatment option for femoro-popliteal lesions in patients with peripheral artery disease (PAD). 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 Dr. 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 7.5 cm lesion in his superficial femoral artery (SFA). “We are honored to enroll the first patient in the CVT-SFA trial,” said Dr. Honton. “We believe this promising new generation of everolimus DCBs could improve patient outcomes for those suffering from peripheral artery disease.”
 
CVT intends to enroll 75 patients at a minimum of four sites in France and Germany to support a U.S. Food and Drug Administration IDE submission and a subsequent U.S. pivotal clinical study.
 
“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,” said Jeffery Chambers, M.D., CSI’s chief medical officer.
 
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.

As many as 18 million Americans, most over age 65, suffer from PAD, which is caused by the accumulation of plaque in peripheral arteries reducing blood flow. Symptoms include leg pain when walking or at rest. Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates.
 
Cardiovascular Systems Inc., based in St. Paul, Minn., develops and commercializes solutions for treating peripheral and coronary vascular disease. The company’s orbital atherectomy system treats calcified and fibrotic plaque in arterial vessels throughout the leg and heart and addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. 
 
Chansu Vascular Technologies LLC (CVT) is a company with its principal office located in Sunnyvale, Calif. CVT was founded by Philippe Marco, M.D., to develop peripheral and coronary DCBs using everolimus. Marco is a 25-year medical technology veteran who has spent his entire career focused on cardiovascular device development. He was president and chief operating officer (COO) of Epix Therapeutics Inc. (acquired by Medtronic), and president and COO at CV Ingenuity (acquired by Covidien), where he was responsible for the development of the Stellarex DCB. Marco started working on cardiovascular drug-delivery devices while in charge of Medical Affairs for Abbott Vascular where, following the Perclose Inc. acquisition, he led the franchise expansion into a diversified portfolio from closure devices to drug-coated coronary stents, embolic protection devices, and peripheral catheters and stents.