Protégé

Protégé (including Protégé NC and Protégé SC) is a next-generation paclitaxel-coated coronary balloon dilatation catheter (drug-coated balloon, DCB) developed by Blue Medical Devices (acquired by Translumina). It is designed for the treatment of complex coronary artery disease, including in-stent restenosis (ISR) and de novo small vessel lesions, following a 'leave nothing behind' strategy. The device utilizes a patented pipette-based drug application method within the balloon folds and a hydrophilic polyvinylpyrrolidone (PVP) coating to minimize drug loss during transition and ensure targeted, uniform delivery of paclitaxel directly to the vessel wall upon inflation. Paclitaxel acts as an anti-proliferative agent by binding to the beta-tubulin subunit of microtubules, hyper-stabilizing their structure, and inhibiting the dynamic disassembly required for mitosis, thereby preventing neointimal hyperplasia and restenosis. Protégé is EU-MDR certified and is being evaluated in the large-scale SPARX global randomized controlled trial comparing a DCB-first strategy against contemporary drug-eluting stents.

Brand names

ProtégéProtégé NCProtégé SC

Other names

Protégé Paclitaxel Coated Coronary Balloon Dilatation CatheterProtégé Paclitaxel-Coated Balloon