Advanced NanoTherapies’ SirPlux Duo DCB Receives FDA Breakthrough Device Designation for Small-Vessel CAD

September 19, 2022—Advanced NanoTherapies, Inc. announced that the FDA has granted Breakthrough Device designation for the company’s SirPlux Duo drug-coated balloon (DCB) for the treatment of coronary artery disease in vessels < 3 mm. The company also recently received Breakthrough Device designations for its SirPlux Duo DCB in coronary in-stent restenosis and peripheral below-the-knee lesions.

According to the company, the SirPlux Duo DCB combines sirolimus and paclitaxel to create a next-generation therapy engineered to provide stent-like patency and restenosis prevention while leaving no implant behind. SirPlux Duo DCB delivers low-dose, long-term release of both compounds to inhibit cell growth. The company’s nanoparticle drug-encapsulation and delivery platform is designed to provide safe, reliable, and sustained bioavailability of the two drugs in tissue for long-term outcomes.

Rishi Puri MD, who is Coprincipal Investigator of the company’s ADVANCE-DCB clinical trial, commented in the press release, “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. 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 revascularizations.”

Dr. Puri is a coronary and structural heart interventional cardiologist in the Tomsich Family Department of Cardiovascular Medicine at the Cleveland Clinic in Cleveland, Ohio.