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

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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