Medtronic’s Prevail Global Pivotal Trial Begins Patient Enrollment

February 26, 2025—Medtronic announced the enrollment of the first patient in the pivotal trial of the company’s Prevail paclitaxel drug-coated balloon (DCB) catheter for in-stent restenosis (ISR) and de novo small vessel disease.

Medtronic stated that findings from the Prevail Global study are intended to support approval of the Prevail DCB in the United States and Japan. In October 2024, the company announced FDA investigational device exemption approval to initiate the trial.

According to Medtronic, the Prevail DCB is intended to be used during percutaneous coronary intervention procedures to treat narrowed or blocked coronary arteries in patients with coronary artery disease (CAD).

The company advised that the multicenter, dual-cohort clinical trial will enroll up to 1,205 patients with CAD from approximately 65 global centers across the United States, Europe, and Asia Pacific.

Medtronic stated that the trial will assess the safety and efficacy of the Prevail DCB for the primary endpoint of target lesion failure at 12 months post procedure. It will include a randomized controlled evaluation of patients with ISR and a single-arm evaluation of patients with de novo small vessel disease, stated the company.

As reported in the company’s press release, the first procedure in the trial was performed by Ziad Ali, MD, Director of DeMatteis Cardiovascular Institute at St Francis Hospital & Heart Center in Roslyn, New York.

“CAD is a chronic condition affecting over 315 million people globally, highlighting the importance of developing innovative and long-lasting solutions to assist patients in maintaining blood flow, whether they have new heart blockages or have been previously treated,” commented Dr. Ali in Medtronic’s press release.

Dr. Ali continued, “In the United States, DCBs have been used for more than a decade in patients with peripheral artery disease. This trial will not only bring the use of this innovative DCB technology to patients with previously treated blockages, where stents have failed, but it will also bring use to new blockages in small vessels where stents might not perform as well in the coronary arteries. We are proud to be enrolling patients in the Prevail Global study.”

The Medtronic press release stated that the Prevail Global study will build upon the extensive commercial experience from the use of the Prevail DCB globally.

In July 2021, Medtronic announced the launch of the Prevail DCB catheter in Europe after receiving CE Mark approval. The device is commercially available in more than 79 countries globally.

Prevail DCB is not approved or sold in the United States or Japan, where it is an investigational device within the Prevail Global study, advised Medtronic.