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Prevail™ DCB The broadest range of CE Mark indications, including in bifurcation lesions¶,11,12

Alert Indications, Safety, and Warnings

Prevail™ drug-coated balloon now has the broadest range of CE Mark indications¶,11,12

Purple circle showing that Prevail™ paclitaxel-coated PTCA balloon catheter has received seven new CE Mark indications.

Prevail™ DCB now has the broadest range of CE Mark indications, including bifurcation.¶,11,12 
The new indications are supported by clinical evidence showing safety and efficacy in a real-world, complex patient population.¶,11,4

 

Table showing that Prevail™ DCB has the broadest range of CE Mark indications, including bifurcation. The new indications are supported by clinical evidence showing safety and efficacy in a real-world, complex patient population.

Prevail™ DCB meets the needs of a complex PCI practice with new indications. It’s the only DCB indicated for treatment of multivessel disease, acute coronary syndrome, and diabetic patients.

View CE Mark summary

The Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

In March 2025, the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) released the largest real-world dataset including nearly 1,800 patients with Prevail™, investigating safety and efficacy.4 The Prevail™ drug-coated balloon (DCB) is a second-generation DCB† offering superior deliverability1 and an innovative coating2 for the treatment of coronary in-stent restenosis, de novo lesions, small vessel disease3, and the 7 new indications, including bifurcation.¶,11,12

Key outcomes from SCAAR data

  • Prevail™ DCB demonstrated low event rates supporting safety and efficacy.4
  • For patients treated with DCB and stent in the same vessel,◊ Prevail™ DCB was associated with lower rates of myocardial infarction.
SCAAR clinical summary

Low 7.2%

all-cause mortality at two years4

View the SCAAR report all-cause mortality chart comparing the Prevail™ PTCA balloon catheter to other DCBs.

6.1%

new myocardial infarction at two years4

View the SCAAR report myocardial infarctions chart comparing the Prevail™ PTCA balloon catheter to other DCBs.

7.4%

target lesion revascularization at two years4

View the SCAAR report target lesion revascularization chart comparing the Prevail™ PTCA balloon catheter to other DCBs.

The registry includes complex patient populations4

Diabetic

31.9%

ACS

61.0%

B2/C lesion

55.3%

Bifurcations

22.8%

Scientific data presented at 2025 CRT conference. 

How Prevail™ works

The Prevail™ DCB offers the performance you are looking for when treating complex lesions during percutaneous coronary interventions. Watch this animation to see how Prevail™ provides:

  • Superior deliverability1
  • Rapid absorption5,6 of the proven7 drug formulation FreePac™
  • Sustained long-term healing§,6

Successful drug delivery6,8

The coating process of the balloon ensures a uniform drug distribution9 with up to 65% of the drug protected within the folds.10 Watch this animation to better understand how this process helps deliver a therapeutic dose to the lesion.

Optimized drug formulation

FreePac™ is the optimized drug formulation applied to the balloon that is designed to treat coronary artery disease. Watch this video to get a better understanding of each component of FreePac™ and how they work together to provide long-term healing.5,6

Download Prevail™ brochure

Want to learn more about DCBs in practice?

Tune into the "DCB Unveiled" podcast series. With over 25,000 listens, this series bridges science and clinical application. Specifically designed for interventional cardiologists, you’ll explore the origins and science behind drug-coated balloons (DCBs), review key clinical data, and discover evolving treatment strategies.

Listen to the podcast now

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Adverse events observed in patients treated with a DCB include, but not limited to, dissection, coronary artery stenosis/re-stenosis, ventricular arrhythmia, unstable angina, and repeat revascularization. Refer to the Prevail™ DCB IFU for more information.
For distribution only in markets where the Prevail™ drug-coated balloon has been approved. Not for distribution in the USA, France, Japan, or Canada. Prevail™ DCB expanded indications are approved in Europe and the United Kingdom.

TM* Third-party brands are trademarks of their respective owners.

† The first-generation of Medtronic DCB was IN.PACT™ Falcon with a closed coating process and smaller size matrix.

‡ Based on bench test data. Bench test data may not be indicative of clinical performance.

§ Animal data may not be indicative of clinical outcomes.

◊ Warning: Drug-eluting stents must not be implanted into the vessel segment that has been treated with a Prevail™ DCB.

¶ Prevail™ DCB expanded indications are approved in EU and UK. 

1. Based on bench test data‡ (D00133639_B), n = 5 , size 3.0x20 of each DCB: IN.PACT™ Falcon, SeQuent®* Please, SeQuent®* Please NEO, Agent™*, MagicTouch™*. Deliverability defined as pushability. 2020.

2. Based on internal report (10213030DOC Rev. 1A), IN.PACT™ Euphora™ design concept document. 2019.

3. Based on M003933C001DOC1_B, Prevail™ instructions for use. 2023.

4. Von Koch S. Real-world Usage of Prevail™ drug-coated balloon compared with other contemporary drug-coated balloon | A two-year analysis from the Swedish Coronary Angiography and Angioplasty (SCAAR) Registry in over 6,000 patients. Presented at CRT 2025; Washington, D.C.

5. Based on internal report (D01177733 Rev. A), Characterization of post-inflation residual drug. 2024.

6. Based on internal report (D00178518_A), Elution evaluation of the Medtronic drug-coated IN.PACT™ Euphora™ balloon in a porcine artery model. 2019.

7. Virmani R. Arterial wall response to drug-coated balloons. Confluence. September 2016;13:15–19.

8. Based on internal report (D00655639_Rev.A), Prevail™ by Medtronic versus SeQuent®* Please Neo by B. Braun coronary drug-coated balloons (DCB) drug “wash-off” study. 2022.

9. Based on internal report (RE-10034), IN.PACT™ Admiral™ verification of coating process optimization. 2019.

10. Based on internal report (D00277875_A), Position paper to measure the percentage of the balloon folds that are ‘internal’ versus ‘external’ for the 3-fold and 5-fold Prevail™ DCBs. 2020.

11. Medtronic data on file.

12. Information comes from key competitive DCB IFUs, or the respective websites accessed in May 2025.

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