FORT WAYNE, Ind. – April 21, 2025 – The Parkview Heart Institute has been selected by medical technology firm Medtronic as one of 65 hospitals globally to participate in a clinical trial of a new heart catheter.
Ireland-based Medtronic recently enrolled its first patient to trial the Prevail™ paclitaxel-coated balloon catheter for in-stent restenosis (ISR) and de novo small vessel disease. These catheters, also known as drug-coated balloons, deliver the drug paclitaxel directly to arterial tissue where it can be absorbed and retained to prevent re-narrowing or blockages in blood vessels after a percutaneous coronary intervention procedure.
The trial will enroll up to 1,205 patients with coronary artery disease from hospitals located in the U.S., Europe and the Asia Pacific. The randomized controlled evaluation will monitor de novo small disease patients to assess the safety and efficacy of the Prevail drug-coated balloon for 12 months post-procedure.
“Our participation in this trial wouldn’t be possible without the Parkview Heart Institute, its physicians, its nurses and the research infrastructure in place at Parkview,” said Dr. Roy Robertson, president of the Parkview Heart Institute and physician executive of specialty service lines at Parkview Health. “We are excited to participate in this trial and look forward to offering this innovative new option to patients requiring coronary intervention. The ability of this drug-coated balloon to deliver anti-narrowing medicine directly to blood vessels during procedures will ideally improve outcomes and reduce complications for our patients.”
Drug-coated balloons have been in use across Europe since 2021, where researchers have conducted 10 trials including more than 1,600 patients. Medtronic’s Prevail product is already approved for use in 79 countries, but not in the United States or Japan. The trial will gather data to support an application for regulatory approval in those two nations.
Ireland is Indiana’s No. 1 import partner, with pharmaceutical products and organic chemicals as the top category of products traded to the state. Parkview Health, through the Mirro Center for Innovation and Research, has a standing relationship with Enterprise Ireland, Ireland’s economic development agency, which opens opportunities for new businesses and products between the two nations through the Mirro Center’s annual innovation competition and other strategic partnerships.
Medtronic, headquartered in Galway, Ireland, is a leading global healthcare technology company of 95,000+ employees across more than 150 countries. Medtronic technologies and therapies are currently used to treat 70 health conditions and include cardiac devices, surgical robots, insulin pumps, surgical tools, patient monitoring systems and more.
“Medtronic is a global leader in healthcare innovation, and the opportunity to partner with them for this exclusive research trial is a major win for Parkview patients,” said Dr. Michael Mirro, chief academic research officer, Parkview Health. “Healthcare is an ever-advancing field of science and Parkview’s investment in research and development is critical to not only bringing the best tools and practices to our patients, but to do our part in advancing healthcare globally, for all people. Our Clinical Research Team has participated in over 1,000 clinical trials of MedTech and pharma products since 1990 in order to bring the best technology to the bedside.”