February 26, 2025Medtronic (NYSE: MDT) announced the successful enrollment of the first patient in its pivotal trial for the Prevail Drug-Coated Balloon (DCB).This study aims to evaluate the efficacy of paclitaxel-coated balloon catheters for in-stent restenosis (ISR) and de novo small vessel disease, marking an important step for Medtronic in the field of cardiovascular interventional therapy.

This trial was led by Dr. Ziad Ali, Director of the DeMatteis Cardiovascular Institute at St. Francis Hospital and Heart Center (New York), and successfully completed the first surgery.Dr. Ali stated, "This trial not only applies this innovative DCB technology to previously treated obstructed patients (those with stent failure) but also to new obstructions in small vessels — a situation where stents may perform poorly in coronary arteries. We are proud to have patients participate in the Prevail Global study, which will provide valuable data support for future treatments."

Medtronic anticipates that data from the Prevail Global study will support DCB approval in the U.S. and Japan. Since its launch in Europe in 2021, the Prevail Drug-Coated Balloon has gained widespread adoption across more than 79 countries/regions. In October this year, Medtronic received Investigational Device Exemption (IDE) approval from the U.S. FDA, enabling it to formally initiate this pivotal clinical trial.

Prevail Drug-Coated Balloon Designed for Percutaneous Coronary Intervention (PCI) Procedures to Treat Narrowed or Blocked Coronary Arteries. During the procedure, the balloon inflates within the artery while delivering medication to the arterial tissue. The arterial tissue absorbs and retains the medication, providing a sustained anti-restenosis effect. This innovative design gives Prevail a significant advantage in treating coronary artery disease.

This study will recruit up to 1,205 patients with coronary artery disease (CAD) across approximately 65 global centers in the United States, Europe, and the Asia-Pacific region.These patients will be treated with Prevail drug-coated balloons, and their efficacy and safety will be verified through strict follow-up and evaluation.

Jason Weidman, Senior Vice President of Medtronic and President of the Coronary and Renal Denervation business, stated: "As a leader in coronary drug-eluting stents and peripheral drug-coated balloons, Medtronic is committed to providing this new evidence to support future regulatory submissions for the Prevail DCB in the United States and Japan. We believe that through this pivotal clinical study, Prevail will further solidify its leading position in the field of cardiovascular interventional therapy."

Medtronic is a global leading medical technology company dedicated to providing lifelong treatment, diagnosis, and monitoring solutions for patients with chronic diseases such as cardiovascular disease, neurology, diabetes, and spinal disorders. Through continuous innovation and research, the company has brought safer and more effective treatment options to patients worldwide. The launch of the pivotal trial for the Prevail drug-coated balloon once again demonstrates Medtronic's strength and commitment in the field of cardiovascular interventional therapy.

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