Cardiovascular Systems recently announced that it has made significant progress towards the commercialisation of intravascular lithotripsy (IVL) systems for the treatment of calcific coronary and peripheral arterial disease.
A press release notes that feasibility testing of a proprietary console and associated IVL balloon catheters is complete. The company’s IVL systems are designed to improve upon the limitations of incumbent technology, the release details, allowing physicians to cross and treat more challenging atherosclerotic lesions.
In coronary, Cardiovascular Systems’ 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 the company to offer products that effectively treat a broader range of calcific coronary lesions, Cardiovascular Systems communicates, tripling their total addressable market (US) to US$1.3 billion. Enrolment of patients in an investigational device exemption study for the Cardiovascular Systems coronary IVL system is currently targeted for calendar 2023.
Cardiovascular Systems’ 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 company’s offering will expand its treatable patient population across an even broader spectrum of calcified arteries above and below the knee, the press release states, thereby increasing Cardiovascular Systems’ addressable market (US) by over 50% to nearly US$1 billion. The company 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 arterial disease will uniquely position Cardiovascular Systems to provide the right device, for the right lesion, for all physicians. We believe the successful execution of this programme will greatly expand patient access to care and Cardiovascular Systems’ overall market position in complex coronary and peripheral disease.”