Medtronic drug-coated balloon gains multiple new approvals

Michael Walter | May 23, 2025 | Cardiovascular Business | Interventional Cardiology

Prevail DCB Medtronic. Medtronic’s Prevail drug-coated balloon (DCB) has received CE mark approval for several new indications related to the treatment of coronary artery disease (CAD). The paclitaxel-coated device, designed to inflate within the patient’s artery during percutaneous coronary intervention (PCI) procedures, is now approved across the EU to treat CAD patients with multivessel disease, acute coronary syndrome and diabetes.

Prevail DCB graphic courtesy of Medtronic.

Medtronic’s Prevail drug-coated balloon (DCB) has received CE mark approval for several new indications related to the treatment of coronary artery disease (CAD). The paclitaxel-coated device, designed to inflate within the patient’s artery during percutaneous coronary intervention (PCI) procedures, is now approved across the European Union to treat CAD patients with multivessel disease, acute coronary syndrome and diabetes.

Announcing the new clearances, Medtronic pointed to recent Prevail data showing two-year event rates of 6.1% for new myocardial infarction, 7.4% for target lesion revascularization and 0.8% for target lesion definite thrombosis. At EuroPCR, the company added, the device was liked to positive one-year data in bifurcation patients.

“The Prevail DCB’s acute performance, clinical data, and expanded indications support the needs of physicians who treat increasingly complex patients,” Jason Weidman, senior vice president and president of Medtronic’s roronary & renal denervation business, said in a statement. “We are taking the same approach we've taken over the years with our drug-eluting stents. By bringing real-world clinical data to the forefront, we can expand use of the Prevail DCB in new patient populations. We look forward to helping even more physicians across the globe access the tools they need to give their patients best-in-class care.”

The Prevail DCB received its initial CE mark approval in 2021, and it is also cleared to use in dozens of other countries, but it has not been approved by the U.S. Food and Drug Administration (FDA).

In February, Medtronic announced the launch of a new global trial focused on evaluating the company’s ability to treat in-stent restenosis and de novo small vessel disease in CAD patients. It is expected to enroll up to 1,205 patients in the United States, Europe and Asia, and Medtronic hopes the findings can help the device finally gain FDA approval.

Medtronic enrolls first patient in new coronary DCB trial—data could lead to FDA approval

Use of biolimus-coated balloons during PCI not as effective as paclitaxel devices

Industry concerns over paclitaxel-coated devices may have put PAD patients at risk

FDA says treating PAD with paclitaxel-coated devices does not increase mortality risk

TAVR vs. surgery, FFR-guided PCI and DCB safety: Day 3 at ACC.22

Michael Walter, Managing Editor

Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.

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