clinical performance and safety of the vector® percutaneous transluminal coronary angioplasty balloon catheter: a single-arm, multicenter, retrospective post-marketing clinical study

Background: the present post-marketing clinical study was conducted over a 12-month follow-up period to monitor the clinical outcomes of patients treated with the vector® percutaneous transluminal coronary angioplasty (ptca) balloon catheter for the dilatation of coronary lesions. the semi-compliant balloon improves balloon-to-vessel wall apposition and minimizes balloon slippage during ptca, which could reduce complications and improve clinical outcomes. this investigation aimed to assess the safety and effectiveness of the vector® ptca balloon catheter in real-world settings.methods: a retrospective study was conducted to investigate the safety and efficacy of the vector® ptca balloon catheter in 125 patients who underwent pre-dilatation and post-dilatation. the primary outcome of the study was major adverse cardiac events (mace), a composite endpoint encompassing target-lesion revascularization (tlr), cardiac death, and myocardial infarction (mi).results: the vector® ptca balloon catheter has shown promising results in a small group of patients undergoing dilatation of normal and intricate coronary artery lesions, reflecting a 100% procedural success rate. the successful delivery to the target lesion, deployment, and subsequent retrieval of the device during the index procedure led to a 100% device success rate without any technical issues. a total of 3.2% (4) patients experienced mace during the 12-month follow-up, with 1.6% (2) mi, 1.6% (2) tlr, and no cardiovascular deaths..conclusion: this study demonstrated the favorable safety and reliability of the vector® ptca balloon catheter in patients with angina, mi, and a history of coronary artery disease in a real-world setting.