Medtronic's Prevail Drug-Coated Balloon Demonstrates Superior Outcomes vs. Biotronik, Boston Scientific, and Others in Real-World Study of Nearly 2,000 Patients

Mar 11, 2025 22:15 CST Updated 22:15

Medtronic

Medical Device Manufacturer

InAt the CRT2025 conference, Medtronic announcedA study onPrevailCompared with other DCB productsReal-world study. The study showsPrevailCompared with other DCB products, it has better therapeutic effects.

This study is based on data analysis from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). As a registry system covering all coronary angiography patients nationwide in Sweden, SCAAR included 1,797 patients in this study, making it the largest DCB comparative study to date. The study compared Prevail with four commonly used DCBs in Sweden (B. Braun's SeQuent Please, Boston Scientific's Agent, Biotronik's Pantera Lux, and Selution). The patient population featured complex characteristics: 61% had acute coronary syndrome, 31.8% had diabetes, 55.3% had complex lesions, 22.8% had bifurcation lesions, and 28% exhibited in-stent restenosis (ISR).

The primary endpoints include all-cause mortality, myocardial infarction (MI), percutaneous coronary intervention (PCI) revascularization, definite thrombosis of the target lesion, and target lesion revascularization.

Specific Results

The 1-year and 2-year mortality rates after the Prevail procedure were 4.7% and 7.2%, respectively, which were better than the 5% and 8.2% in other DCB groups.
Prevail Surgery Success Rate Reaches 98.7%, Target Lesion Thrombosis Rate Significantly Lower Than Control Group (0.8% vs 1.3% at 2 Years). In Hybrid PCI (Combination of DCB and Stent in the Same Vessel), the Prevail Group Exhibited a Lower Incidence of New MI.

Executive Evaluation

"Faced with increasingly complex coronary lesion patients, the continuous accumulation of clinical evidence for Prevail is crucial. Since its launch in 2021, its differentiated design has gained widespread market recognition, and the new data will further enhance its clinical application. These findings underscore the company's commitment to advancing complex PCI solutions."

---Jason Weidman President of Medtronic Cardiovascular Business, Coronary & Renal Denervation Division

Currently, Prevail has been launched in more than 80 countries worldwide. In 2024, the FDA approved the IDE study, and last month, Medtronic initiated the Prevail Global study and completed the enrollment of the first patient.

Prevail

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。

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 cardiac surgery, malignant and non-malignant pain, movement disorders, diabetes, gastrointestinal diseases, urological conditions, spinal disorders, neurological diseases, and ENT surgical treatments.