Medtronic Announces Completion of Drug-Coated BalloonPrevailThe first clinical enrollment in the global clinical study (Prevail Global).
Prevail Global is aA multicenter, dual-cohort clinical trial will recruit 1,205 patients with coronary heart disease across approximately 65 global centers in the United States, Europe, and the Asia-Pacific region. The trial will include a randomized controlled evaluation of ISR patients and a single-arm evaluation of de novo small vessel disease patients to assess the safety and efficacy of Prevail at 12 months post-procedure for the primary endpoint of target lesion failure.
"Coronary artery disease (CAD) is a chronic condition that affects more than 315 million people worldwide, underscoring the importance of developing innovative and lasting solutions to help patients maintain blood flow, whether they are suffering from new heart blockages or have been previously treated. In the United States, drug-coated balloons have been used in patients with peripheral artery disease for over a decade. This trial not only applies this innovative DCB technology to patients with previously treated obstructions, i.e., those with stent failure, but also to new obstructions in small vessels where stents may perform poorly in coronary arteries. We are proud to enroll patients in the Prevail Global study."---Ziad Ali St Francis Hospital & Heart Center "The enrollment of the first patient in the Prevail Global study is a key milestone as we aim to provide innovation in complex percutaneous coronary interventions for clinicians. 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 in the United States and Japan."---Jason Weidman, Senior Vice President of Medtronic Cardiovascular Portfolio and President of Coronary and Renal Denervation BusinessSince 2021YearPrevailSince receiving CE approval for market release (for the treatment of new coronary artery lesions, in-stent restenosis, and small vessel disease), it has been launched in 79 countries worldwide. Among them,PrevailThe drug-coated FREEPAC has been extensively proven in coronary and peripheral arteries, with over 10 trials and 1,600 patients studied for the FREEPAC drug-coating technology treatment. Therefore, its safety and effectiveness are trustworthy.According to the previous information, a subgroup in this study (treatmentISR) The control group used products from Boston Scientific.Agent (Already approved by the FDA for marketing)Used forDrug-eluting balloon for the treatment of in-stent restenosis in coronary arteries, with over 100,000 surgeries performed globally). Therefore, there is great anticipationPrevailWhich is better, Agent or not, I don't know.PrevailWhether it can replicate the miracle of its TAVR products.
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, makingPrevailOwnIn 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 manifestation of dilated cardiomyopathy.Exhibiting favorable late lumen loss（0.05±0.44 mm）。
AndPrevailWith strong safety features, including no stent thrombosis, target vessel myocardial infarction (TVMI), or cardiac-relatedSex-related mortality, all patients had a lower rate of clinically-driven target lesion revascularization within 1 year (6%).
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 cardiac support, minimally invasive cardiac surgery, malignant and non-malignant pain, movement disorders, diabetes, gastrointestinal diseases, urological conditions, spinal disorders, neurological diseases, and ENT surgical treatments.
