Comprehensive Preclinical Evaluation of the Valvuloplasty Embossing Balloon: Thrombo-Resistance and Safety in a Porcine Model

The study investigated the thrombo-resistance of the Valvuloplasty Embossing Balloon in a clinically relevant Porcine model. Male swine were chosen for preclinical testing, following standard fasting protocols to mitigate potential confounders. The balloon was deployed in the descending thoracic aorta, aided by a guide wire, to circumvent complications associated with valvular space inflation. Despite the inability to reach valvular space, the study aimed to evaluate the device's thrombogenicity. Angiographic imaging revealed the balloon's excellent performance, maintaining consistent retrograde contrast flow during inflation and deflation without thrombus formation. Post-procedural examination showed no signs of thrombus formation or coagulation on the balloon's surface or at the target sites. Additionally, necropsy findings confirmed the absence of thrombus formation or injury to the aorta's luminal interface, indicating the device's thrombo-resistance. Hematology and clinical chemistry parameters remained stable before and after the procedure, affirming the absence of systemic effects. The mean thrombus formation score of 0 indicated no significant thrombosis, highlighting the device's thrombo-resistant nature. Notably, no adverse events or safety concerns were reported. In conclusion, the Valvuloplasty Embossing Balloon demonstrated thrombo-resistance in the porcine model, supporting its safety and efficacy for clinical use in valvuloplasty procedures. Key words: Thrombo-resistance, Valvuloplasty Embossing Balloon, Porcine Model, thrombogenicity, angiographic imaging, necropsy findings, thrombus formation.