CSI’s Intravascular Lithotripsy Technology Completes Feasibility Testing for Treating CAD and PAD

January 13, 2022—Cardiovascular Systems, Inc. (CSI) announced it has made significant progress toward the commercialization of intravascular lithotripsy (IVL) systems for the treatment of calcific coronary and peripheral artery disease.

According to CSI, feasibility testing of the company’s console and associated IVL balloon catheters is complete. The company stated that the CSI IVL systems are designed to improve upon the limitations of incumbent technology, allowing physicians to cross and treat more challenging atherosclerotic lesions. Commercialization of the IVL systems will be complementary to CSI’s broader portfolio of vessel preparation technologies, noted the company.

CSI noted that lithotripsy uses noninvasive high-pressure waves to fracture and disrupt pathologic solid masses. Used successfully for many years in the treatment of kidney and gall stones, lithotripsy more recently has found application in the treatment of calcified coronary and peripheral arteries.

In coronary applications, CSI’s current product offering, which is focused on the treatment of severely calcified coronary arteries using orbital atherectomy, targets 12% of percutaneous coronary interventions. The addition of a coronary IVL system will enable CSI to offer products that effectively treat a broader range of calcific coronary lesions. Enrollment of patients in an investigational device exemption study for the CSI coronary IVL system is currently targeted for calendar 2023.

CSI’s peripheral orbital atherectomy devices are primarily used to treat long, diffuse calcified arteries below the knee. Introducing a peripheral IVL system to the CSI portfolio will expand its treatable patient population across a broader spectrum of calcified arteries above and below the knee. CSI plans to begin first-in-human evaluations for the peripheral IVL system in calendar 2023.