Advanced NanoTherapies’ SirPlux Duo Drug-Coated Balloon Receives FDA Breakthrough Designation for Small Vessel Coronary Artery Disease
Advanced NanoTherapies, Inc., a privately-held medical device company committed to solving vascular disease’s most significant challenges through the creative applications of nanotechnology, announced the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its SirPlux Duo Drug-Coated Balloon (DCB) for coronary artery disease in vessels less than 3.0mm. This achievement comes only weeks 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 Dr. Rishi Puri MD, Ph.D., Coronary and Structural Heart Interventional Cardiologist in the Tomsich Family Department of Cardiovascular Medicine at Cleveland Clinic and 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 revascularizations.”
Small vessel disease (SVD), defined as atherosclerosis within small (<3mm) coronary vessels, reaches roughly 1 in 3 of patients with symptomatic coronary artery disease (CAD), especially patients with chronic kidney disease (CKD), diabetes mellitus, and active smokers. The most powerful predictor of angiographic restenosis following treatment is the diameter of the vessel, with a 60% higher risk of restenosis for each decrease of 0.50 mm. The clinical profile of 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, favorable vascular remodeling, and shortened dual antiplatelet therapy.
The SirPlux Duo DCB combines the synergistic power of Sirolimus and Paclitaxel to create a next-generation, front-line 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, resulting in maximum potency exceeding any other DCB or drug-eluting stent.4 The Company’s proprietary nanoparticle drug-encapsulation and delivery platform provides safe, reliable, and sustained bioavailability of the two synergistic drugs in tissue for long-term outcomes.
“Our third breakthrough designation emphasizes the urgent need for new coronary and peripheral therapies with a leave nothing behind approach,” said Marwan Berrada-Sounni, Co-Founder and CEO of Advanced NanoTherapies. “We appreciate the collaborative approach the FDA has taken to reviewing our technology and the novelty of combining two synergistic drugs. Over the coming months, we will build on this positive momentum as we generate first-in-human clinical data using the SirPlux Duo DCB.”