Medtronic (NYSE: MDT) announced today that investigators enrolled the first patient in a pivotal trial of its Prevail drug-coated balloon (DCB).
The study evaluates the paclitaxel-coated balloon catheter for in-stent restenosis (ISR) and de novo small vessel disease. Dr. Ziad Ali, director of the DeMatteis Cardiovascular Institute at St Francis Hospital & Heart Center (New York) performed the first procedure.
“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,” said Ali. “We are proud to be enrolling patients in the Prevail Global study.”
Medtronic expects data from its Prevail Global study to support approval of the DCB in the U.S. and Japan. Prevail currently has availability in more than 79 countries, including across Europe, where it launched in 2021. The medtech giant won FDA investigational device exemption (IDE) picked up in October, which enabled it to conduct this study.
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 study will enroll up to 1,205 patients with CAD across approximately 65 global centers in the U.S., Europe and Asia Pacific.
“As a leader in coronary drug eluting stents and peripheral drug-coated balloons, Medtronic is committed to delivering this new evidence to support future regulatory submissions for Prevail DCB in the U.S. and Japan,” said Jason Weidman, SVP and president of the Coronary and Renal Denervation business at Medtronic.
