Medtronic's Prevail Drug-Coated Balloon Receives FDA IDE Approval for Pivotal Trial
Key Insights
Medtronic has received FDA approval for an IDE to begin a pivotal clinical trial of its Prevail drug-coated balloon (DCB).
The trial will evaluate the safety and efficacy of Prevail DCB (search) for in-stent restenosis (search) (ISR) and de novo small vessel disease.
The study will enroll 1,205 patients across 65 global centers and include a head-to-head comparison of two drug-coated balloons.
Medtronic has secured FDA approval for an investigational device exemption (IDE) to initiate a pivotal clinical trial of its Prevail coronary paclitaxel drug-coated balloon (DCB). The Prevail Global Study will generate data to support regulatory submissions for the treatment of coronary artery disease (search) in both the U.S. and Japan.
The multi-center, dual cohort trial will enroll up to 1,205 patients with coronary artery disease (search) across approximately 65 centers in the U.S., Europe, and Asia Pacific. The trial design includes a randomized controlled evaluation of ISR patients and a single-arm evaluation of de novo small vessel disease patients, both aimed at assessing the safety and efficacy of the Prevail DCB (search).
Trial Design and Endpoints
The ISR cohort will randomize patients 1:1 to either the Medtronic Prevail DCB (search) or the Boston Scientific AGENT™ DCB to assess non-inferiority. The de novo small vessel (DNSV) cohort will compare the Prevail DCB against drug-eluting stents, the standard of care for small vessel treatment, using a historical control from the Resolute Onyx Clinical Program. The primary endpoint for both cohorts is target lesion failure (TLF) at 12 months, with patient follow-up extending to five years.
Expert Commentary
"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. "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."
Prevail DCB Technology
The Prevail DCB (search) is designed for use during percutaneous coronary intervention (PCI) procedures to treat narrowed or blocked coronary arteries in patients with coronary artery disease (search). During the procedure, the balloon is inflated within the artery, delivering paclitaxel to the arterial tissue, where it is absorbed and retained to provide a durable anti-restenotic effect.
Medtronic's Perspective
"The launch of the Prevail IDE study underscores our commitment to pioneering advanced solutions for complex PCI," stated Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business at Medtronic. "The Prevail DCB (search) 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."
Global Availability and Future Plans
The Prevail DCB (search) is currently available in more than 79 countries globally, having launched in Europe in 2021 with indications for de novo lesions, in-stent restenosis (search), and small vessel disease. The Prevail DCB is investigational within the Prevail Global Study and is not yet approved or sold in the U.S. or Japan.