Medtronic Gets FDA IDE Nod for Prevail Drug-Coated Balloon Study

Medtronic has earned investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin the pivotal trial of its Prevail coronary paclitaxel drug-coated balloon (DCB) for in stent restenosis (ISR) and de novo small vessel disease.
 
The trial will enroll up to 1,205 patients with coronary artery disease from about 65 centers across the U.S., Europe, and Asia Pacific. The trial will include randomized, controlled evaluation of ISR patients and a single arm evaluation of de novo small vessel disease patients to assess the Prevail DCB’s safety and efficacy.
 
The Prevail DCB is intended to be used during percutaneous coronary intervention (PCI) procedures to treat narrowed or blocked coronary arteries in patients with coronary artery disease. During the catheter-based procedure, the balloon inflates in the artery, while the drug (paclitaxel) is delivered to the arterial tissue, where it is absorbed and retained to provide a durable anti-restenotic effect.
 
The Prevail Global Study will build on the extensive experience from use of Prevail DCB globally. Prevail DCB was launched in Europe in 2021 with indications to treat de novo lesions, in-stent restenosis, and small vessel disease in the coronary arteries. Its FreePac coating has an extensive body of evidence in both coronary and peripheral artery disease with over 10 trials and 1,600 patients studied.
 
“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,” said David Kandzari, M.D., chief, Piedmont Heart Institute and Cardiovascular Services in Atlanta and co-principal investigator of the Prevail Global Study. “Drug-coated balloons provide clinicians with an anti-restenosis solution, without the need of a permanent stent. This groundbreaking trial will include the first head-to-head randomized trial of two drug coated balloons in the U.S. and will provide important additional evidence for this growing therapy.”
 
“The launch of the Prevail IDE study underscores our commitment to pioneering advanced solutions for complex PCI,” stated Jason Weidman, senior VP and president of Medtronic’s Coronary and Renal Denervation business. “The Prevail DCB has the potential to be a significant advancement in the coronary market. Medtronic is proud to invest in the expansion of clinical evidence to bring Prevail to patients globally. As a leader in drug and device combination therapies for vascular diseases, we look forward to collaborating closely with study investigators and the FDA to initiate patient enrollment in the forthcoming months.”