Recently,Medtronic (NYSE: MDT) announced the results of a registry study that highlightedPrevail Drug-Coated Balloon (DCB)Effectiveness.At the 2025 Cardiovascular Research Technologies (CRT) ConferenceDr. Sacharias von Koch from the Department of Cardiology at Skåne University Hospital, Lund University, Sweden, shared the findings of the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) study.The SCAAR study includes1,797Patients, including61%Patients with acute coronary syndrome,31.8%Patients with diabetes,55.3%Patients with complex lesions,22.8%Patients with bifurcation lesions and28%Patients with in-stent restenosis (ISR).
The research results includeAll-cause mortality, myocardial infarction (MI), new revascularization through percutaneous coronary intervention (PCI), target lesion definite thrombosis, and target lesion revascularization。
Prevail One Year After Surgery（4.7%）And Two Years（7.2%）The mortality rate is lower. The success rate of the surgery is98.7%. The thrombosis rate of its target lesions was relatively low (at two years0.8%, other DCBs were 1.3%).The study results showed that the performance of Prevail was not inferior compared to other DCB products used in the study during the same period.PrevailLaunched in Europe in 2021，Currently, including Europe,More than 70Available in China. Received the FDA's Investigational Device Exemption (IDE) in October 2024.Medtronic announced last month that the first patient has been enrolled in the Prevail global study to support regulatory approvals in the United States and Japan.
Prevail Drug-Coated Balloon (DCB)
Prevail™ Paclitaxel-Coated PTCA Balloon Catheter is a high-performance medical device specifically designed for the treatment of coronary artery lesions, suitable for percutaneous coronary intervention (PCI) in cases of in-stent restenosis (ISR), de novo lesions, and small vessel disease.
Excellent Delivery Performance:Utilizing PowerTrac™ technology and a hydrophilic coating significantly enhances deliverability. The ultra-thin balloon material optimizes folding performance, while the low-profile marker band and tapered tip design reduce resistance during passage, ensuring ease of operation. Compatible with a 5F guiding catheter, it offers a wide range of applications.FreePac™ Coating Has Strong Evidence Support in Coronary and Peripheral Artery Diseases, with Over 10 Trials Conducted and 1,600 Patients Studied.Powerful Push Capability:According to Medtronic's description, the pushability of the Prevail™ DCB is twice that of the IN.PACT™ FALCON DCB, significantly enhancing the pushing force, which makes it perform better in handling complex lesions.Highly Effective Drug Coating:Paclitaxel is a potent anti-restenosis drug that can continuously function in tissues throughout the entire healing process. Urea, as a biocompatible excipient, enables rapid and reliable drug transfer within 30-60 seconds.Prevail™ Paclitaxel-Coated PTCA Balloon Catheter provides a reliable solution for the treatment of complex coronary artery lesions, assisting doctors in achieving more precise and effective operations in percutaneous coronary intervention. Specific product models are shown in the figure below:Comparison of Pushability of Prevail™ DCB (Drug-Coated Balloon)According to the data,The pushability of Prevail™ DCB is nearly twice that of IN.PACT™ FALCON DCB (210 vs 106).The maximum transmission forces of other several DCBs are: 148 pf for SeQuent™ Please NEO DCB, 141 pf for AGENT™ DCB, and 176 pf for Magic Touch™ DCB.Overall, the Prevail™ DCB performs excellently in pushability, surpassing several other DCB products.Based on the research data above,The patient at 6 months post-operationLumen loss is very low, with an average of 0.05 ± 0.44 mm and a maximum acceptance rate of 0.5 mm. Specifically, the late lumen loss for new lesions was 0.12 ± 0.45 mm, while the late lumen loss for in-stent restenosis was -0.04 ± 0.41 mm.In addition, all patients within 6 monthsNot occurredStent thrombosis, target vessel myocardial infarction, or cardiac death.
The incidence rates show that the rates of target lesion failure (TLF), cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization (CD-TLR), and stent thrombosis were all0%。
These results indicate that the Prevail™ DCB has very low late lumen loss and good clinical outcomes within 6 months.
Successful Enrollment of the First PatientIn February 2025, Medtronic announced its Prevail™ Paclitaxel-Coated Balloon Catheter (also known as a drug-coated balloon).Capsule) used forIn-Stent Restenosis (ISR) and Primary Small Vessel DiseaseThe clinical trial has successfully recruited the first patient.The first surgery of this trial was performed by Dr. Ziad Ali, Director of the DeMatteis Cardiovascular Institute at St. Francis Hospital and Heart Center in New York.This multi-center, dual-cohort clinical trial will recruit participants from approximately the United States, Europe, and the Asia-Pacific region.65Global Center Recruits the Most1205 NamesPatients with coronary artery disease.The trial will include a randomized controlled evaluation in ISR patients and a single-arm assessment in primary small vessel disease patients to evaluate the safety and efficacy of the Prevail DCB for the primary endpoint of target lesion failure at 12 months post-procedure.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 who have previously been treated but experienced stent failure, but also to new blockages in small and medium-sized coronary arteries, where stents may not perform well.Source of the article:
https://www.massdevice.com/sweden-registry-medtronic-drug-coated-balloon/
