Feasibility and safety of the new coronary noncompliant balloon catheter River NC®

Abstract

Aim: In this preliminary study, we aimed to confirm the clinical utility and safety of the new noncompliant balloon catheter River NC® (Balton, Poland). Materials & methods: The primary study end point was to verify balloon diameters calculated in quantitative coronary angiography (QCA) to diameters prespecified by the manufacturer and obtained at given pressures in subjects undergoing percutaneous coronary interventions. Results: Forty-two subjects were enrolled (73.8% multivessel disease; 40.5% type B1 lesions; 100% device success). No clinically significant differences between expected balloon diameters and QCA were registered in predilatation (2.36 ± 0.11 mm vs 2.43 ± 0.07 mm) and postdilatation (3.18 ± 0.19 mm vs 3.21 ± 0.31 mm). Conclusion: Our study results suggest that the River NC balloon is effective and safe. In the QCA evaluation, River NC balloon obtained prespecified diameters and lengths at applied pressures. Study registration: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (UR.D.WM.DNB.109.2019).