ArticleCureus2025
Evaluation of Clinical Safety and Performance of the Pipit-NC Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter in Coronary Artery Stenosis: A Post-market Clinical Study.
Article in Cureus, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
3 authors.
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Abstract
aimThe present study aimed to evaluate the clinical safety and performance of the Pipit-NC PTCA balloon dilatation catheter (Sahajanand Medical Technologies Limited, Surat, India) in real-world PCI procedures for the treatment of coronary artery stenosis. MATERIALS AND
methodsThis was a prospective, observational, single-center, single-arm, investigator-initiated, post-market clinical study that enrolled 87 patients who were treated with at least one Pipit-NC PTCA balloon dilatation catheter during their index PCI procedure. The primary endpoints were device success and procedural success. Secondary endpoints included procedural complications and in-hospital safety outcomes, such as all-cause mortality, any myocardial infarction, and any revascularization.
resultsA total of 134 Pipit-NC PTCA balloon catheters were utilized during the index procedures in 87 patients (mean age 60.68 ± 10.99 years; 79.3% male) with 90 coronary lesions, including 44 balloons for pre-dilation and 90 for post-dilatation. The treated lesion included 47 (52.2%) calcified lesions, 16 (17.8%) chronic total occlusions, and 10 (11.1%) lesions in tortuous vessels. The balloon demonstrated consistent performance during both pre-dilatation (mean pressure: 16.86 ± 1.85 atm) and post-dilatation (mean pressure: 25.93 ± 2.97 atm). The Pipit-NC balloon achieved 100% device success - meeting all criteria for safe and effective delivery, function, and retrieval - and 100% procedural success, with no in-hospital target lesion failure events observed.
conclusionThe Pipit-NC PTCA balloon dilatation catheter demonstrated excellent clinical safety and performance in real-world clinical practice, achieving 100% device and procedural success without complications, even in complex coronary lesions. Its effectiveness in both pre- and post-dilatation applications supports its utility in index PCI procedures.
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