Paclitaxel Coated Coronary
Balloon Dilatation Catheter
Taking DCB technology to a New High
Introducing our innovative drug-coated balloon (DCB), a pioneering therapeutic device that enhances the treatment of coronary artery disease through precision-targeted, transient local drug delivery. This advanced modality creates a strategic “window of opportunity” for optimal vascular healing and restenosis prevention.
Available in semi-compliant and non-compliant variants, Protégé is uniquely positioned in the market to meet diverse clinical needs with tailored balloon compliance.
PACLITAXEL
- Drug of Choice for DCB in Coronary Interventions with Large Clinical Evidence1
- Apoptotic effect of Paclitaxel reduces toxicity2
- Positive vessel remodelling with late lumen enlargement3
1. European Heart Journal (2018)00, 1-23 Doi:10.1093/eurheartj/ehy394 2. Rev. Cardiovasc. Med. 2021vol.22(4),1323-1330 3. Clin Res Cardiol (2015) 104:217–225 4. Circ Res. 2000;86:879-884
Technology
Unique Drug Application
Drug is applied through auto pipette technology with in the balloon folds ensuring minimum drug loss
Wing Seal Technology
Wrapped balloon is crimped & then subjected to a process that creates corrugation
- Crimping prevents balloon unfolding during advancement and minimizes drug loss
- Surface corrugation creates low balloon profile for better flexibility & deliverability even in complex anatomy
- Corrugation reduces frictional abrasion during balloon advancement
Drug Release
- The coating acts as sponge which elutes the drug only when pressure is applied
- Paclitaxel is released from the coating after first inflation to the target vessel
M3i Study
-
Multiple Drug Release*
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
PEARL Study
Proven safety and efficacy of the Protégé*
In real-world PCI of In-Stent Restenosis (ISR) and De Novo Lesions
- Highly Complex Lesion classified type C - 36%
- Prior PCI - 86.4%
- ISR DES - 60.4%
- Diabetes - 28.3%
Conclusions:
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%)
At 2 Years, Protégé showed (11.7%) TLR in ISR which is lower compared to other DCBs in clinical registries**
*Cheng et al., 2022, J. Invasive Cardiol. 34(6) – Pearl Registry: Paclitaxel-coated balloon in PCI practice.
**European Heart Journal (2020) 41.3715-3728 doc 10.1093/eurheart/ehz594
Size Catheter
Protégé DCB Catheter
Technical Specification
Protégé DCB Catheter
