Medtronic Receives IDE Approval for Pivotal Trial of Prevail DCB

October 23, 2024—Medtronic announced that the FDA has granted investigational device exemption approval to initiate the pivotal clinical trial of the company’s Prevail coronary paclitaxel drug-coated balloon (DCB) for in-stent restenosis (ISR) and de novo small vessel disease. The company advised that data from the Prevail Global Clinical Program will be used to support approval of the Prevail DCB in Japan and the United States.

According to Medtronic, the multicenter, dual-cohort clinical trial will enroll up to 1,205 patients with coronary artery disease from approximately 65 global centers across the United States, Europe, and Asia Pacific. The trial will include a randomized controlled evaluation of ISR patients and a single-arm evaluation of de novo small vessel disease patients to assess the safety and efficacy of the Prevail DCB.

The ISR cohort will randomize patients 1:1 with the Medtronic Prevail DCB and Boston Scientific Agent DCB to assess noninferiority. The ISR cohort will be led David Kandzari, MD, and Bruno Scheller, MD.

Dr. Kandzari is Chief of Piedmont Heart Institute and Cardiovascular Services in Atlanta, Georgia. Prof. Scheller is Professor for Clinical and Experimental Interventional Cardiology at Saarland University in Saarbrücken, Germany. Dr. Kandzari also serves as Coprincipal Investigator of the Prevail Global Study.

“As physicians treat more patients with complex lesions, it is important to have a device that helps to maintain durable patency while preserving future treatment options,” commented Dr. Kandzari in Medtronic’s press release. “DCBs provide clinicians with an antirestenosis solution, without the need of a permanent stent. This groundbreaking trial will include the first head-to-head randomized trial of two DCBs in the United States and will provide important additional evidence for this growing therapy.”

The de novo small vessel cohort will compare Prevail DCB against drug-eluting stents—the standard of care for small vessel treatment—using a historical control from the extensive body of evidence from the Resolute Onyx (Medtronic) clinical program. The primary endpoint for both cohorts will be target lesion failure at 12 months. Patients will be followed out to 5 years.

Azeem Latib, MD, and Darren Mylotte, MD, will lead the de novo small vessel cohort. Dr. Latib is with Montefiore Medical Center and White Plains Hospital in White Plains, New York. Dr. Mylotte is with Galway University Hospital and School of Medicine at University of Galway in Ireland.

Prevail DCB was launched in Europe in 2021 with indications for the treatment of de novo lesions, ISR, and small vessel disease in the coronary arteries. It is commercially available in > 79 countries globally. Prevail DCB is not approved or sold in the United States or Japan. Within the Prevail Global Study, Prevail DCB is investigational, advised the company.