Dr. Sacharias von Koch of the Deptartment of Cardiology and Clinical Sciences at Lund University, Skåne University Hospital in Sweden presented findings from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) at Cardiovascular Research Technologies (CRT) 2025 in Washington, D.C.
Findings demonstrated comparable outcomes with Prevail compared to other contemporary DCBs used in the study. This suggests Prevail is an effective treatment for a variety of complex coronary lesions.
SCAAR included 1,797 patients. It compared Prevail to other DCBs in a complex patient population. That included 61% patients with acute coronary syndrome, 31.8% with diabetes, 55.3% with complex lesions, 22.8% with bifurcation lesions and 28% in-stent restenosis (ISR). Outcomes included all-cause mortality, myocardial infarction (MI), new revascularization with percutaneous coronary intervention (PCI), target lesion definite thrombosis and target lesion revascularization.
Prevail demonstrated low mortality event rates at one year (4.7%) and two years (7.2%) post-procedure. Outcomes showed a 98.7% procedure success rate with Prevail as well. It had low rates of target lesion thrombosis (0.8% at two years compared to 1.3% with other DCBs).
Prevail currently has availability in more than 80 countries, including across Europe, where it launched in 2021. The medtech giant won FDA investigational device exemption (IDE) picked up in October. Medtronic announced the first enrolled patient in the Prevail Global study to support U.S. and Japanese approval last month.
“As physicians encounter and treat an increasing number of patients with complex lesions, it is crucial to continuously gather data on our Prevail DCB,” stated Jason Weidman, SVP and president of the Coronary and Renal Denervation business at Medtronic. “With its differentiated design, Prevail has seen strong market adoptions since 2021, and we are eager to see how this new data will further advance the Prevail DCB in the market. These findings reaffirm Medtronic’s dedication to advancing complex PCI solutions, ultimately bringing this procedure to patients worldwide.”
