Breakthrough device designation granted for SirPlux Duo coronary DCB in small vessels

SirPlux Duo drug-coated balloon (DCB)

Advanced NanoTherapies has been granted US Food and Drug Administration (FDA) breakthrough device designation for its SirPlux Duo drug-coated balloon (DCB) for coronary artery disease in vessels less than 3mm.

This comes shortly after the company received two other critical breakthrough device designations for its SirPlux Duo DCB in coronary in-stent restenosis (ISR) and peripheral below-the-knee (BTK) lesions.

“Despite decades of advances in drug-eluting stents, treating small coronary vessels continues to be challenging due to the unacceptable incidence of restenosis and target lesion failure,” commented Rishi Puri (Cleveland Clinic, Cleveland, USA), co-principal investigator of the company’s ADVANCE-DCB clinical trial. “Advanced NanoTherapies is championing a novel stent-free option to address this clinical gap. I look forward to seeing how this technology can advance the field of coronary interventions by improving long-term clinical outcomes and preventing the need for repeat revascularisations.”

The clinical profile of small vessel disease (SVD) patients translates into poor long-term outcomes, including a higher rate of target lesion failure when using drug-eluting stents (DES). DCBs are becoming an attractive therapeutic strategy for de novo lesions, with potential advantages of lower risk of acute thrombosis, favourable vascular remodelling, and shortened dual antiplatelet therapy (DAPT), Advanced NanoTherapies said in a press release.

SirPlux Duo DCB delivers low-dose, long-term release of sirolimus and paclitaxel to inhibit cell growth. Advanced NanoTherapies’ proprietary nanoparticle drug-encapsulation and delivery platform provides safe, reliable, and sustained bioavailability of the two synergistic drugs in tissue for long-term outcomes, the company adds.


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