Medtronic (NYSE: MDT) announced today that it received FDA investigational device exemption (IDE) for its Prevail drug-coated balloon (DCB).
The medtech giant can now begin a pivotal clinical trial for the coronary paclitaxel DCB for in-stent restenosis (ISR) and de novo small vessel disease. It plans to use data from its Prevail Global Clinical Program to support approval efforts in Japan and the U.S. Prevail currently has availability in more than 79 countries, including across Europe, where it launched in 2021.
Medtronic said expects the multi-center, dual-cohort trial to enroll up to 1,205 patients with coronary artery disease. It takes place across approximately 65 global centers in the U.S., Europe and Asia Pacific. The trial includes a randomized controlled evaluation of ISR patients and a single-arm evaluation of de novo small vessel patients. Ultimately, it aims to assess the safety and efficacy of the Prevail DCB.
The ISR cohort randomizes patients 1:1 with the Prevail DCB and Boston Scientific’s Agent DCB to assess non-inferiority. The de novo small vessel cohort pits Prevail against drug-eluting stents, the standard of care for small vessel treatment. Both cohorts have a primary endpoint of target lesion failure (TLF) at 12 months. Investigators plan to follow patients out to five years.
Prevail offers use in percutaneous coronary intervention (PCI) procedures to treat narrowed or blocked coronary arteries. During a catheter-based procedure, the balloon inflates within the artery. Meanwhile, the drug goes to the arterial tissue, which absorbs and retains it, providing a durable, anti-restenotic effect.
“The launch of the Prevail IDE study underscores our commitment to pioneering advanced solutions for complex PCI,” said Jason Weidman, SVP and president of the Coronary and Renal Denervation business at Medtronic. “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.”
