Clinical Outcomes of a Non-Compliant Balloon Dilatation Catheter: MOZEC™ NC Study

Akshyaya Pradhan (), Pravesh Vishwakarma, Monika Bhandari, Rishi Sethi, Sharad Chandra, Gaurav Chaudhary, Akhil Sharma, Marco Alfonso Perrone, Sudhanshu Dwivedi and Varun Narain
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Akshyaya Pradhan: Department of Cardiology, King George’s Medical University, Lucknow 226003, India
Pravesh Vishwakarma: Department of Cardiology, King George’s Medical University, Lucknow 226003, India
Monika Bhandari: Department of Cardiology, King George’s Medical University, Lucknow 226003, India
Rishi Sethi: Department of Cardiology, King George’s Medical University, Lucknow 226003, India
Sharad Chandra: Department of Cardiology, King George’s Medical University, Lucknow 226003, India
Gaurav Chaudhary: Department of Cardiology, King George’s Medical University, Lucknow 226003, India
Akhil Sharma: Department of Cardiology, King George’s Medical University, Lucknow 226003, India
Marco Alfonso Perrone: Department of Cardiology and Cardio Lab, University of Rome Tor Vergata, 00133 Rome, Italy
Sudhanshu Dwivedi: Department of Cardiology, King George’s Medical University, Lucknow 226003, India
Varun Narain: Department of Cardiology, King George’s Medical University, Lucknow 226003, India

IJERPH, 2022, vol. 19, issue 23, 1-10

Abstract: The present study sought to assess the clinical outcomes of the Mozec™ Non-compliant (NC) Rx PTCA balloon dilatation catheter (BDC) (Meril Life Sciences Pvt. Ltd., Vapi, India) for dilatation of coronary lesions. This was a post-marketing, single-centre, single-arm, retrospective study. In total, 57 patients who had undergone post-dilatation with the Mozec™ NC Rx PTCA balloon dilatation catheter were evaluated. The primary endpoint was procedural success defined as (i) successful delivery of the investigational device to and across the target lesion; (ii) successful inflation, deflation, and withdrawal of the investigational device; (iii) absence of vessel perforation, flow-limiting vessel dissection, increase in thrombolysis in myocardial infarction (TIMI) flow from baseline, clinically significant arrhythmia requiring medical treatment; and (iv) achievement of final TIMI flow grade 3 after percutaneous coronary intervention of the target lesion after single or multiple attempts to cross the target lesion. Procedural success was achieved in 57 (100%) patients. There were no incidences of major adverse cardiac events (MACE)/target lesion failure (TLF). Mozec™ NC Rx PTCA balloon dilatation catheter has demonstrated favourable outcomes for the dilatation of routine and complex coronary lesions in a small cohort, as evidenced by its 100% procedural success rate and absence of MACE.

Keywords: balloon angioplasty; coronary stenosis; non-compliant balloons; percutaneous coronary intervention (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
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