Safety and Performance of the MOZEC Sirolimus-Eluting Coronary Balloon in the Treatment of Stenotic Coronary Artery Lesions: A Real-World, Multicenter, Post-Marketing Surveillance Study.

Abstract

Background: Drug-eluting balloons, surface-coated with antiproliferative agents such as sirolimus or paclitaxel, have emerged as an alternative therapeutic option for coronary stenosis. This study evaluated safety and effectiveness of the MOZEC sirolimus-eluting percutaneous transluminal coronary angioplasty (PTCA) balloon dilation catheter (Meril Life Sciences Pvt. Ltd., India) across diverse clinical scenarios in coronary artery stenosis treatment.

Methods: A prospective, single-arm, multicenter, real-world, post-marketing surveillance study evaluated the safety and performance of the MOZEC sirolimus-eluting balloon (SEB) in treating native coronary artery disease in daily clinical practice. Patients were followed for 24 months, with clinical visits or telephonic calls at 1, 6, 12, and 24 months after the index procedure. Safety endpoints included major adverse cardiac events (MACEs), and performance endpoints include change in late lumen loss, clinical success, and device success.

Results: A total of 141 patients were enrolled in the study. The MOZEC SEB was used in 127 (70.17%) de novo lesions, 40 (22.1%) in-stent restenosis lesions, and 14 (7.73%) bifurcations lesions. Over the 24-month follow-up period (n = 134), six cumulative MACEs (4.47%) were observed, comprising two cardiac deaths (1.49%), five myocardial infarctions (3.73%), and four target lesion revascularizations (2.99%). Late lumen loss analysis included 17 patients who underwent additional coronarography at the 6-month follow-up. In-segment and in-device late lumen loss at 6-month follow-up was 0.14 ± 0.37 mm.

Conclusions: The application of MOZEC SEB in various clinical scenarios demonstrated safety and efficacy over long-term follow-up. These findings align with the favorable vessel healing observed during the 6-month imaging follow-up.