Cardiovascular Breakthrough: Medtronic’s Prevail Drug-Coated Balloon Receives Expanded CE Mark for Multiple New Indications

(1) Multi-vessel disease

Patients with multi-vessel disease often have two or more coronary arteries with severe stenosis or occlusion. The condition of these patients is extremely complex, with extensive myocardial ischemia and significantly impaired cardiac function. Their quality of life decreases dramatically—daily activities slightly restricted may trigger symptoms such as angina—and the risk of myocardial infarction, heart failure, or even sudden death increases significantly. Relevant studies indicate that the incidence of cardiovascular events in patients with multi-vessel disease is several times higher than in those with single-vessel disease, posing a significant threat to life and health.

Prevail Drug-Coated Balloon Demonstrates Unique Advantages in Treating Multi-Vessel Disease. Its advanced design and efficient drug delivery system enable precise targeting of each diseased vessel, allowing for effective one-time treatment of multiple lesioned vessels. Compared with traditional treatment methods, the use of Prevail DCB can reduce the number of stents implanted, minimize the retention of intravascular foreign bodies, thereby lowering the risks of thrombosis and restenosis, and improving long-term vascular patency, providing stronger assurance for patients' heart health.

(II) Acute Coronary Syndrome

Acute Coronary Syndrome is a group of severe cardiovascular diseases, including unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction, characterized by sudden onset and rapid progression. Patients often experience intense chest pain, which may radiate to the shoulder, arm, neck, and other areas, and may also be accompanied by symptoms such as shortness of breath, sweating, nausea, and vomiting. In severe cases, it can lead to cardiac arrest, endangering life. Once the disease occurs, effective treatment measures must be taken within a short time; otherwise, the mortality rate is extremely high.

When facing patients with acute coronary syndrome, time is life. The Prevail drug-coated balloon can meet the strict requirements for time and effectiveness in acute treatment. It can rapidly expand during emergency PCI procedures, quickly release the drug to the lesion site, effectively inhibit the proliferation of vascular smooth muscle cells, reduce thrombosis, swiftly restore blood flow in the coronary arteries, alleviate myocardial ischemia symptoms, buy precious rescue time for patients, and greatly improve the success rate of rescuing patients with acute coronary syndrome and their quality of life.

(III) Coronary Artery Disease in Patients with Diabetes

There is a close association between diabetes and coronary artery disease. A prolonged state of high blood sugar can damage vascular endothelial cells, promoting the occurrence and development of atherosclerosis, which increases the risk of coronary artery disease in diabetic patients by 2 to 4 times compared to the general population. Moreover, when diabetic patients develop coronary artery disease as a complication, their condition tends to be more complex and severe, with greater treatment difficulty and poorer prognosis. Not only do they have extensive and serious vascular lesions, but they are also prone to diffuse and multi-vessel disease, with a higher incidence of restenosis after surgery.

Prevail Drug-Coated Balloon Holds Significant Importance for Patients with Diabetes and Coronary Artery Disease. Its unique drug-coating technology better addresses the characteristics of vascular lesions in diabetic patients, effectively reducing the incidence of postoperative restenosis. Compared to traditional treatment methods, using Prevail DCB can minimize vascular damage, avoid potential risks associated with long-term retention of metal stents, and provide a safer and more effective treatment option for diabetic patients. This helps improve their cardiovascular health, enhance quality of life, and extend lifespan.

(1) Main Data Display

On the stage of clinical research, the Prevail drug-coated balloon has gained the trust of many doctors and patients with its outstanding performance. From the grand stage of the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), we can clearly see its excellent results.

In this study, 1,797 patients were enrolled, including 61% with acute coronary syndrome, 31.8% with diabetes, 55.3% with complex lesions, 22.8% with bifurcation lesions, and 28% with in-stent restenosis (ISR). The study results covered several key endpoints, such as all-cause mortality, myocardial infarction (MI), new vessel revascularization via percutaneous coronary intervention (PCI), definite thrombosis of the target lesion, and target lesion revascularization.

Prevail had a remarkably low mortality rate of 4.7% at one year post-surgery, increasing only slightly to 7.2% at two years, with an impressive surgical success rate of 98.7%. The target lesion thrombosis rate was just 0.8% at two years, significantly lower than the 1.3% observed with other drug-coated balloons (DCBs). Regarding new lesions, late lumen loss was 0.12 ± 0.45 mm, while late lumen loss for in-stent restenosis was -0.04 ± 0.41 mm. Notably, no cases of stent thrombosis, target vessel myocardial infarction, or cardiac death occurred within six months among all patients. These figures serve as compelling evidence of Prevail’s powerful therapeutic efficacy, reinforcing its role in safeguarding patients’ health.

(II) Data Comparative Analysis

Compared with other similar products, the Prevail drug-coated balloon has obvious advantages. In terms of pushability, the push performance of Prevail™ DCB is almost twice that of IN.PACT™ FALCON DCB, reaching 210, while IN.PACT™ FALCON DCB is only 106. Other several DCBs, such as SeQuent™ Please NEO DCB, are 148 pf, AGENT™ DCB is 141 pf, and Magic Touch™ DCB is 176 pf. Prevail performs outstandingly in this aspect and is more adaptable to the treatment needs of complex lesions.

The thrombosis rate in target lesions was 0.8% for Prevail at two years, compared to 1.3% for other DCBs. Prevail was significantly lower, indicating that the use of Prevail drug-coated balloons can reduce the risk of postoperative thrombosis and enhance treatment safety.

Compared with traditional treatment methods, the Prevail drug-coated balloon also demonstrates unique advantages. Traditional coronary intervention often uses bare-metal stents; however, bare-metal stents can lead to 0.8mm of late lumen loss, which easily triggers restenosis events. In contrast, the late lumen loss of the Prevail drug-coated balloon at 6 months is very low, averaging 0.05 ± 0.44 mm, with a maximum acceptance rate of 0.5 mm, significantly reducing the incidence of restenosis and providing patients with more durable vascular patency. In treating in-stent restenosis after endovascular treatment for femoropopliteal artery atherosclerotic occlusive disease, the primary patency rate of patients using drug-coated balloons was significantly higher than that of conventional balloons at 12 months post-surgery (83.7% vs. 62.5%), with a statistically significant difference. The advantage of the Prevail drug-coated balloon in this area is also evident.

(1) Coatings and Drug Delivery Systems

Prevail Drug-Coated Balloon Adopts Unique FreePac™ Coating Technology, Combining Paclitaxel Nanocrystals with Hydrophilic Polymers. This innovative composite technology enables the drug to achieve rapid and uniform distribution on the vascular wall. In vitro experiments show that within 60 minutes after drug release, the vascular wall concentration can reach up to 1.2 μg/mm², far exceeding the anti-restenosis threshold, providing sufficient drug assurance for effectively inhibiting vascular smooth muscle cell proliferation.

Paclitaxel, as a potent anti-restenosis drug, can be retained for a long time during the vascular tissue healing process, continuously inhibiting the proliferation of vascular smooth muscle cells and preventing restenosis at its root. The addition of hydrophilic polymers not only enhances the stability of the drug but also improves its release kinetics, enabling more precise and sustained action on the lesion site. The application of this composite technology significantly enhances the therapeutic effect of the drug, providing patients with a higher quality treatment experience.

(II) Delivery Performance Related Technologies

To enhance the operational convenience and adaptability of the balloon in complex vascular environments, the Prevail Drug-Coated Balloon incorporates PowerTrac™ technology and a hydrophilic coating. PowerTrac™ technology improves the balloon's pushability, making it easier and more controllable when navigating tortuous vessels. This allows physicians to deliver the balloon to the lesion site with greater precision, significantly increasing the success rate and safety of the procedure.

The application of hydrophilic coating further reduces the friction between the balloon and the vessel wall, allowing for smoother delivery of the balloon within the vessel. Meanwhile, the low-profile design of the balloon also enhances its trackability, enabling it to better adapt to complex anatomical structures. Even in narrow and tortuous vessels, it can move forward easily, bringing therapeutic hope to more patients.

(1) Review of Development History

In 2021, the Prevail drug-coated balloon successfully obtained its initial CE mark approval, a milestone event that marked its official entry into the medical market stage, commencing its journey of serving patients. Since then, Medtronic has not ceased its exploratory efforts but has continued to invest substantial human, material, and financial resources into the in-depth research and improvement of the Prevail DCB.

During the R&D process, Medtronic's research team continuously optimized the performance and quality of the product. Through extensive clinical trials and data analysis, they made multiple adjustments and improvements to the product's coating technology, drug-release system, and balloon design. They actively collected clinical feedback, maintained close communication with doctors and patients, understood the needs and issues in real-world applications, and carried out targeted improvements.

After relentless efforts, Prevail drug-coated balloon has continuously achieved breakthroughs in technology and clinical applications, gradually gaining recognition worldwide. It is now available in more than 70 countries, including Europe. The recent CE mark approval for multiple new indications is a high recognition of its years of R&D achievements, marking another significant milestone in its development journey, bringing new treatment hope to more patients.

(II) Future Research and Market Expansion Plans

Medtronic understands that in order to benefit more patients with the Prevail drug-coated balloon, it is necessary to continuously expand its application scope and market coverage. Currently, Medtronic is actively promoting a global trial for FDA approval in the United States. This multi-center, dual-cohort clinical trial is expected to be conducted across approximately 65 global centers in the United States, Europe, and the Asia-Pacific region, with plans to recruit up to 1,205 patients with coronary artery disease.

The trial is comprehensive and rigorous, including randomized controlled evaluations of patients with in-stent restenosis (ISR) and single-arm assessments of patients with de novo small vessel disease. The ultimate goal is to comprehensively and thoroughly evaluate the safety and efficacy of the Prevail drug-coated balloon (DCB). If the trial is successful, the Prevail DCB is expected to receive approval from the U.S. FDA, thereby entering the vast U.S. market and providing more treatment options for American patients.

Apart from the U.S. market, Medtronic also plans to promote the Prevail Drug-Coated Balloon (DCB) in more countries and regions. They will collaborate closely with local medical institutions, doctors, and research teams to conduct clinical trials, collect clinical data, understand the needs and characteristics of local patients, and make full preparations for the localized promotion of the product. Medtronic will also strengthen marketing and promotional efforts to increase the product's recognition and acceptance, allowing more doctors and patients to understand the advantages and efficacy of the Prevail DCB.

Medtronic will continue to invest in research and development, exploring the combined application of the Prevail drug-coated balloon with other treatment methods, as well as its potential applications in more disease areas, constantly tapping into the product's potential to bring more innovation and breakthroughs in the treatment of cardiovascular diseases.

This Issue's Planning: Shen Li

Editorial Responsibility: Chen Baolin

Author of this article: Yun Ye Xuan

Post-production: Zhang Lirong