IVL for calcified lesions: Where the technology stands now and where it's headed

Intravascular lithotripsy (IVL) is an “intuitive and attractive” technique for treating severely calcified lesions, according to a new analysis in Circulation: Cardiovascular Interventions.

IVL, which uses small electrical charges—or “shock waves”—in a balloon-based system, was developed by Shockwave Medical. The company’s IVL system was designed to be used by clinicians in an inpatient or outpatient setting.

The authors of the analysis provided detailed insight into how the process works, noting that it has been found to produce “significant luminal gain and facilitating optimal stent expansion.” They also highlighted IVL’s potential for helping with the treatment of coronary artery disease (CAD). While the technology has received a CE mark for treating calcified coronary lesions in Europe, studies are still underway that could lead to approval in the United States, Japan and elsewhere.

“In due course, randomized clinical trials directly comparing IVL with the currently used techniques such as high-pressure balloon dilatation or adjunctive atherectomy may be needed to firmly establish the relative merits of IVL and its place in the algorithms for treatment of heavily calcified lesions, and therefore its long-term viability as a key adjunctive technology in transcatheter cardiovascular procedures,” wrote lead author Keyvan Karimi Galougahi, MD, a cardiologist at the University of Sydney, and colleagues.

Galougahi et al. also noted that IVL’s safety profile appears to be better than other treatment methods, describing the technique as “incredibly safe.”

Click here for the full assessment.

Some contributors to this study did disclose consulting fees from, and equity in, Shockwave Medical.

A sign of acceptance

In June 2020, CMS issued new codes for IVL procedures. The total count included four new HCPCS codes and 17 ICD-10 codes.

“The appreciation for IVL’s unique ability to safely and effectively treat these challenging patients is growing globally and we are grateful that CMS has taken this important first step on the path towards establishing a reimbursement level that appropriately reflects the clinical value delivered by IVL,” Doug Godshall, Shockwave Medical CEO and president, said at the time.