Cardiovascular Systems To Develop IVL Technology For Coronary, Peripheral Artery Diseases

Cardiovascular Systems Inc 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.
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