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Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today it has made significant progress towards the commercialization of intravascular lithotripsy (IVL) systems for the treatment of calcific coronary and peripheral artery disease.

Lithotripsy is a medical procedure that uses non-invasive high-pressure waves to fracture and disrupt pathologic solid masses. Lithotripsy has been used successfully for many years in the treatment of kidney and gall stones, and more recently has found application in treatment of calcified coronary and peripheral arteries.

Feasibility testing of a proprietary console and associated IVL balloon catheters is complete. 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 highly complementary to CSI’s broader portfolio of advanced vessel preparation technologies.

In coronary, 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 (PCI). The addition of a coronary IVL system will enable CSI to offer products that effectively treat a broader range of calcific coronary lesions, tripling CSI’s total addressable market (U.S.) to $1.3 billion. 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 by physicians to treat long, diffuse calcified arteries below the knee. Introducing a peripheral IVL system to the CSI offering will expand its treatable patient population across an even broader spectrum of calcified arteries above and below the knee, thereby increasing CSI’s addressable market (U.S.) by over 50% to nearly $1 billion. CSI plans to begin first in-human experience for the peripheral IVL system in calendar 2023.

Scott R. Ward, Chairman, President and CEO, said, “The development of an IVL system for the treatment of coronary and peripheral artery disease will uniquely position CSI to provide the right device, for the right lesion, for all physicians. We believe the successful execution of this program will greatly expand patient access to care and CSI’s overall market position in complex coronary and peripheral disease.”