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,

SUBMITTER: Premchand Jain RK 

PROVIDER: S-EPMC11882231 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature