Protégé Paclitaxel Coated Coronary Balloon Dilatation Catheter

Taking DCB technology to a New High

Drug-coated balloon (DCB) treatment follows a leave-nothing-behind concept, delivering uniform drug to the vessel wall and releasing it immediately without a polymer. It lowers the intensity and duration of antiplatelet therapy and leaves no residual material. As a next-generation drug-eluting balloon, Protégé ensures efficient delivery, clinical safety, and long-term outcomes without the risks of permanent implants.

Manufactured by Blue Medical Devices B.V. in the Netherlands EU-MDR Certified

Protégé is powered with technology offering patient benefits with maximum drug available at the lesion site.

As an advanced drug-coated balloon catheter, Protégé is engineered with patented technology that ensures minimal drug loss during transition and targeted, uniform drug delivery. This innovation supports effective treatment while leaving no implant behind.

Protégé is worlds 1st and only DCB Available in both semi-complaint and non-compliant version.

*Desmet, W. J., De Scheerder, I. K., Barrios, L., & Piessens, J. H. (1997). Catheter Cardiovasc Diagn, 41(1), 5–11.
**Amstutz, C., Behr, J., Krebs, S., Haeberlin, A., Vogel, R., Zurbuchen, A., & Burge, J. (2023). BioMedical Engineering OnLine, 22(94)

Technology Highlights

Unique Drug Application

Drug is applied through pipette method within the balloon folds ensuring minimum drug loss during transition.

PVP Coating

Paclitaxel is applied over PVP coating which acts as sponge which elutes the Paclitaxel only when pressure is applied.

Wing Seal Technology

Wrapped balloon is further crimped & then subjected to a process that creates corrugation on ballon surface offering:

Multiple Inflation

Multiple Drug Release upto 3 times with the same device.

Multiple inflations were performed at a different location, the difference in tissue bound paclitaxel was found to be greater. This was attributed to diffusion characteristics. 3rd Inflation provides 1µmol/l of tissue bound paclitaxel which is minimal optimal dosage to as efficiently as possible inhibit the SMC’s

Clinical Evidence

Highlights of Pearl Registry

Proven safety and efficacy of the Protégé*
In real-world PCI of In-Stent Restenosis (ISR) and De Novo Lesions

*Cheng et al., 2022, J. Invasive Cardiol. 34(6) – Pearl Registry: Paclitaxel-coated balloon in PCI practice.

Study Design

Multicentre, Real World, Single Arm , Observational study conducted at Netherlands

At 2 years MACE driven by TLR in patients treated for ISR was 11.7% & for De Novo Lesions 2.9% which is lower compared to the reported incidence rates in ISR patients (>15%)

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Aug 22 Time 19:30 pm

DEB Talks | Drug Coated Balloons in Era of Modern PCI

Join us for an exclusive session of 𝐃𝐄𝐁𝐓𝐚𝐥𝐤𝐬 where top experts will explore the latest breakthroughs in drug delivery and vascular healing using ad...