Advanced NanoTherapies, Inc discovered novel SirPlux Duo Drug-Coated Balloon (DCB) for the treatment of small vessel coronary artery disease less than 3.0mm.
The discovery of novel SirPlux Duo Drug-Coated Balloon (DCB) becomes a stent-free option to fill this clinical gap.
Although having various advancement in drug-eluting stents, treatment of small coronary vessels has become a challenge due to the unacceptable incidence of restenosis and target lesion failure.
The most powerful predictor of angiographic restenosis during the treatment with diameter of the vessel, results in 60% higher risk of restenosis for each decrease of 0.50 mm. Moreover, the clinical profile states that SVD patients translate into poor long-term outcomes, resulting in high rate of target lesion failure while using drug-eluting stents (DES).
Due to its potential advantages of having lower risk of acute thrombosis, favorable vascular remodeling, and shortened dual antiplatelet therapy, DCBs have become an potential therapeutic strategy for de novo lesions.
Small vessel disease (SVD), known as atherosclerosis within small (<3mm) coronary vessels, is noticed rarely among 1 in 3 of patients suffering with symptomatic coronary artery disease (CAD), especially in patients with chronic kidney disease (CKD), diabetes mellitus, and active smokers.
U.S. Food and Drug Administration (FDA) grants Breakthrough Device designation for SirPlux Duo Drug-Coated Balloon (DCB) for Small Vessel Coronary Arteries.