The company is planning to commence first in-human experience for the peripheral IVL system in 2023
CSI’s IVL systems to treat CAD and PAD. (Credit: StockSnap from Pixabay.)
Cardiovascular Systems (CSI) has announced the commercialisation of its intravascular lithotripsy (IVL) systems for the treatment of calcific coronary and peripheral artery disease.
Lithotripsy is a medical procedure that leverages non-invasive high-pressure waves to fracture and disrupt pathologic solid masses.
The technology has been used in the treatment of kidney and gall stones, and was recently found to treat calcified coronary and peripheral arteries.
CSI said that its IVL systems have been designed to improve the limitations of incumbent technology, and enable physicians to treat more challenging atherosclerotic lesions.
The company has completed the feasibility testing of the unique console and related IVL balloon catheters.
It is planning to commence first in-human experience for the peripheral IVL system in 2023.
CSI chairman, president and CEO Scott R Ward 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.”
According to CSI, rolling out of IVL systems will complement its wide-ranging portfolio of advanced vessel preparation technologies.
Its current offering in coronary is focused on treating severely calcified coronary arteries using orbital atherectomy, which targets 12% of percutaneous coronary interventions (PCI).
With the addition of a coronary IVL system, the company is enabled to expand its range of offerings for calcific coronary lesions, tripling its total addressable market to $1.3bn.
CSI is planning to start enrolling patients in its investigational device exemption study for the coronary IVL system in 2023.
The company’s peripheral orbital atherectomy devices are primarily used for the treatment of long, diffuse calcified arteries below the knee.
With the roll out of its peripheral IVL systems, CSI would expand its capabilities to treat patients across a wide spectrum of calcified arteries above and below the knee.
CSI is a medical device company, engaged in developing and marketing advanced interventional treatment systems for peripheral and coronary artery diseases.