2025Year5Month22Day,Medtronic (NYSE:MDT) Announce，ItsPrevailPaclitaxel-Coated Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter (Drug-Coated Balloon,DCB) ObtainCELogo Extended Certification, Becoming the World's Only Approved Treatment for Multi-Vessel Disease (MVD), Acute Coronary Syndrome (ACS) and the treatment of complex coronary artery disease in diabetic patientsDCBProduct.This certification marks the clinical value of the device in high-difficulty scenarios such as bifurcation lesions being officially recognized by authoritative bodies.

This timePrevailPaclitaxel-Coated Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter (Drug-Coated Balloon,DCBTheCECertification Scope Upgrade，New AdditionFinishedBifurcation Lesion (Bifurcation Lesions) Indications, covering complex anatomical structures such as left main bifurcation and true bifurcation，Extended to diabetes mellitus with coronary artery disease,ACSHigh-risk groups such as those with subsequent lesions。Becoming the first product to be simultaneously approved forMVD、ACS, Diabetic PatientsDCBInstrument。

This approval is attributed to the strongClinical Data Support。Based on Real-World Complex Patient Cohorts (Including the Proportion of Bifurcation Lesions)42%, Proportion of Diabetes35%) of3A follow-up study over the years has shown:

• 1Annual incidence rate of myocardial infarction:2.3%(Control Group5.1%）

• Target Lesion Revascularization Rate (TLR）：2.8%(Control Group7.6%）

• Target Lesion Thrombosis Rate:0%(Control Group1.2%）

• Different Strategies for Bifurcation Lesions (Provisional/T-stenting/Culotte) Low consistency in event rates, verifying the general applicability of the device

The ProductTechnical AdvantagesInDifferentiated Coatings and Drug Delivery Systems。Paclitaxel Nanocrystals Combined with Hydrophilic Polymers for Rapid and Uniform Distribution of the Drug on Vascular Walls。In vitro experiments showed that after drug release60Vascular wall concentration reached within minutes1.2μg/mm² (Far exceeding the anti-restenosis threshold)。

"PrevailThe extended indication certification validatesDCBThe value in complex lesions, particularly the data on bifurcation lesions, is especially encouraging."German Heart CenterChristian WeissThe professor pointed out,"InSYNTAXScore ≥32Among the high-risk patients,DCBMay become an effective alternative to stent implantation."

President of Medtronic Coronary Artery BusinessJason WeidmanIndicates:"We are throughPrevail GlobalResearch on Building Coverage Worldwide15A real-world evidence network in China, with the goal of2028Achieve full access to the three major markets of Europe, America, and Japan before the year. Future exploration willDCBCombined application with bioresorbable scaffolds offers an optimal solution for coronary intervention."