MedtronicAnnouncing its next-generation coronary drug-coated balloon---PrevailReceived FDA approval to conduct an IDE clinical study. This study will involve a multicenter, dual-cohort trial that will recruit up to 1,205 patients with coronary artery disease across approximately 65 centers in the United States, Europe, and the Asia-Pacific region, aiming to evaluatePrevaiThe safety and effectiveness of l."The launch of the Prevail IDE study highlights our commitment to pioneering advanced solutions for complex percutaneous coronary interventions. The Prevail DCB has the potential to achieve significant progress in the coronary artery market. Medtronic is proud to invest in expanding clinical evidence, bringing Prevail to patients worldwide. As a leader in combination therapies of drugs and devices for vascular diseases, we look forward to collaborating closely with researchers and the FDA to begin patient enrollment in the coming months."---Jason Weidman Senior Vice President of MedtronicDrug-coated balloons for the treatment of coronary artery stenosis, occlusion, or in-stent restenosis after coronary stenting have been proven to be safe and effective. For example, Boston Scientific's drug-coated...Balloon Agent DCB has been tested in over 100,000 surgeries clinically and received FDA approval this May, becoming the first FDA-approved device forDrug-eluting balloon for the treatment of coronary artery in-stent restenosis.PrevailCompared to Agent DCB, it is somewhat behind in terms of registration and commercialization progress. HoweverForPrevailThere is also a late-mover advantage, as the control group in this clinical study was chosen accordingly.Agent DCB. Once clinical research data shows superiority overAgent DCB will accelerate Medtronic's commercial promotion. Like TAVR, it will achieve later but surpass first.Medtronic Chooses Agent DCB as the Control Group, Believing Medtronic forPrevailStill very confident. After allPrevailReceived CE approval in 2021, subsequently gained approval for marketing in 79 countries, and has already been validated in the market.
PrevailIt is a drug-coated balloon that adopts the FREEPAC drug-loading technology.Prevail uses paclitaxel as the drug and urea as the carrier (allowing the drug to achieve rapid and reliable transfer within 30–60 seconds).The drug-loading technology is similar to the marketed In Pact Admin.
PrevailProduct Structure:
PrevailAdopted PowerTrac technology, makingPrevailPossessIn Pact AdminTwice the pushing force, thereforePrevailWith betterDelivery Capability,Thereby enabling better control of the curved anatomical structure。
In the PREVISE study,PrevailShowed excellent clinical performance in patients with complex lesions, including patients with small vessels and those receiving treatment for in-stent restenosis. At 6 months, the primary manifestations of dilated cardiomyopathy were observed.Excellent late lumen loss（0.05±0.44 mm）。
AndPrevailWith strong safety, including no stent thrombosis, target vessel myocardial infarction (TVMI), or cardiacSex-related mortality, all patients had a low rate (6%) of clinically-driven target lesion revascularization within 1 year.
Prevail Demonstration
Medtronic
Medtronic, founded in 1949 and headquartered in Minneapolis, Minnesota, USA, is a global leader in medical technology dedicated to providing lifelong treatment solutions for patients with chronic diseases. Medtronic's main products cover areas such as arrhythmia, heart failure, vascular diseases, heart valve replacement, extracorporeal heart support, minimally invasive heart surgery, malignant and non-malignant pain, movement disorders, diabetes, gastrointestinal diseases, urological conditions, spinal disorders, neurological diseases, and surgeries related to otolaryngology.
