Patient Enrollment Begins in Everolimus Drug-Coated Balloon Study

Cardiovascular Systems Inc. (CSI) has begun enrolling patients in its coronary everolimus drug-coated balloon study.

The first patient was treated by Dr. Iraki Gogorishvili, 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,” Gogorishvili said. 

The coronary DCB was used to treat in-stent restenosis (ISR) located in the left anterior descending artery. The balloon involved in this first-in-human trial was developed by Chansu Vascular Technologies LLC (CVT). CSI is providing milestone-based financing to CVT for the development of coronary and peripheral DCBs. Under an acquisition option agreement, CSI has exclusive rights to acquire CVT upon completion of certain technical and clinical milestones in the development program.
 
DCBs are a widely accepted percutaneous interventional treatment option for femoro-popliteal lesions in patients with peripheral artery disease, and are increasingly recognized for their potential in complex coronary artery disease, ISR, small vessels, and bifurcation lesions. 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 CVT DCBs are designed to capitalize on the proven long-standing anti-restenotic benefits of everolimus for the treatment of patients with cardiovascular lesions. CVT 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,” said Ryan Egeland, M.D., Ph.D., CSI’s chief medical officer. 

CAD is a life-threatening condition and a leading cause of death in men and women globally. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or more of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. According to the Centers for Disease Control and Prevention, 18.2 million people in the United States have CAD, the most common form of heart disease. Heart disease claims more than 650,000 lives in the United States each year. According to estimates, significant arterial calcium is present in about 30 percent of patients undergoing a PCI. Significant calcium contributes to poor stent delivery, expansion and wall apposition leading to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse cardiac events (MACE).
 
Based in St. Paul, Minn., CSI develops and commercializes solutions for treating vascular and coronary 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 is 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 (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 drug delivery cardiovascular 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.