Medtronic’s Prevail DCB Evaluated in SCAAR Analysis

March 12, 2025—Medtronic recently announced results from an analysis of the company’s Prevail paclitaxel drug-coated balloon (DCB) catheter in the SCAAR registry. The company stated that the Prevail DCB is intended for use during percutaneous coronary intervention (PCI) procedures to treat narrowed or blocked coronary arteries in patients with coronary artery disease.

The results were presented by Sacharias von Koch, MD, as a late-breaking clinical trial at CRT 25, the Cardiovascular Research Technologies annual meeting held March 8-11 in Washington, DC. Dr. von Koch is with the Department of Cardiology and Clinical Sciences at Lund University, Skåne University Hospital in Lund, Sweden.

The company stated that the real-world analysis from SCAAR is comparing different types of DCBs and is the largest dataset evaluating the Prevail DCB, with 1,797 patients. The nationwide registry includes data on all patients in Sweden undergoing coronary angiography.

According to Medtronic, the real-world data showed that the Prevail DCB has comparable outcomes with other contemporary DCBs used in the study, suggesting the Prevail is as effective a treatment for a variety of complex coronary lesions.

As summarized in the press release, the analysis from the registry was composed of a complex patient population including those with acute coronary syndrome (61%), diabetes (31.8%), complex lesions (55.3%), bifurcation lesions (22.8%), and in-stent restenosis (28%). Outcomes included all-cause mortality, myocardial infarction (MI), new revascularization with PCI, target lesion definite thrombosis, and target lesion revascularization.

Medtronic reported that the Prevail DCB demonstrated mortality event rates of 4.7% at 1 year and 7.2% at 2 years. Additionally, the outcomes showed a 98.7% procedure success rate with the Prevail DCB and very low rates of target lesion thrombosis (0.8% at 2 years vs 1.3% with other DCBs). In hybrid PCI (defined as DCB and stent in the same vessel), Prevail showed lower new MI rates versus other contemporary DCBs.

Medtronic advised that the Prevail DCB is commercially available in more than 80 countries globally. The device is not approved or sold in the United States or Japan.

In the United States, the FDA approved an investigational device exemption for the Prevail DCB in October 2024 to begin the pivotal Prevail Global study. On February 26, Medtronic announced enrollment of the first patient in the pivotal trial of the Prevail DCB for in-stent restenosis and de novo small vessel disease, stated the company.