Medtronic Launches Global Trial for Prevail Drug-Coated Balloon in Coronary Artery Disease

Key Insights

• Medtronic has initiated patient enrollment in a global trial evaluating the Prevail paclitaxel-coated balloon catheter for treating in-stent restenosis and small vessel disease in coronary artery disease patients.
• The trial aims to enroll 1,205 patients across the US, Europe, and Asia, with the primary endpoint measuring target lesion failure at one year post-treatment.
• The Prevail DCB, already CE-marked since 2001, could potentially gain FDA approval in the United States, where coronary drug-coated balloons are just beginning to gain regulatory acceptance.

Medtronic has launched a significant global clinical trial investigating its Prevail paclitaxel-coated balloon catheter (DCB) for coronary interventions, marking a crucial step toward potential FDA approval for treating coronary artery disease (CAD).

The first procedure in this landmark study was performed by Dr. Ziad Ali, director of the DeMatteis Cardiovascular Institute at St. Francis Hospital and Heart Center in New York. The trial focuses on two specific applications: treating in-stent restenosis (ISR) and de novo small vessel disease in CAD patients.

Disease Burden and Treatment Need

"CAD is a chronic condition affecting over 315 million people globally, highlighting the importance of developing innovative and long-lasting solutions," stated Dr. Ali. The disease requires effective interventions to maintain blood flow in both new blockages and previously treated vessels.

Technology and Mechanism of Action

The Prevail DCB employs a specialized FreePac coating technology that delivers paclitaxel directly to arterial tissue during percutaneous coronary intervention (PCI). This targeted drug delivery mechanism is designed to prevent the recurrence of in-stent restenosis, potentially reducing the need for repeat hospitalizations. The coating technology has demonstrated effectiveness in both coronary and peripheral artery disease applications.

Trial Design and Objectives

The Prevail Global study aims to enroll up to 1,205 patients across multiple continents, including the United States, Europe, and Asia. The trial's primary endpoint will evaluate target lesion failure at one year post-treatment, focusing on the device's safety and effectiveness in treating both ISR and de novo small vessel disease.

Regulatory Status and Market Context

While the Prevail DCB has held CE mark approval since 2001 and is available in numerous countries, this trial represents a strategic move toward expanding its regulatory approvals. The timing is particularly relevant as coronary DCBs are gaining momentum in the United States, exemplified by Boston Scientific's recent FDA approval for their Agent DCB in March 2024.

Clinical Impact and Future Implications

"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," Dr. Ali explained, highlighting the potential therapeutic impact of this technology.