Clinical performance and safety of the Vector® percutaneous transluminal coronary angioplasty balloon catheter: A single-arm, multicenter, retrospective post-marketing clinical study.

Abstract

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.