Cardiovascular Systems Inc (NASDAQ:CSII) has announced the development of intravascular lithotripsy (IVL) technology for coronary and peripheral artery diseases.
- Enrolling patients in an investigational device exemption study for the CSI coronary IVL system is currently targeted for calendar 2023.
- Lithotripsy is a medical procedure that uses non-invasive high-pressure waves to fracture and disrupt pathologic solid masses.
- 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.
- IVL 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.
- Commercialization of the IVL systems will complement CSI's portfolio of advanced vessel preparation technologies.
- In coronary, CSI's current product offering, which focuses on treating severely calcified coronary arteries using orbital atherectomy, targets 12% of percutaneous coronary interventions.
- The company plans to begin the first-in-human experience for the peripheral IVL system in calendar 2023.
- Price Action: CSII shares closed 0.33% lower at $18.07 on Thursday.
