IN-VITRO SIMULATION TEST METHODOLOGY OF THE VALVULOPLASTY EMBOSSING BALLOON SYSTEM: AN INNOVATIVE APPROACH TO AORTIC VALVE STENOSIS TREATMENT

Cardiac stroke is the most leading cause of death these days. The frequency of heart defects are being diagnosed more and more frequently these days. A variety of heart diseases exist, each with its own causes, symptoms and treatments. Cardiovascular diseases (CVDs), are a group of conditions that affect the heart and blood vessels. They are the leading cause of death globally. Aortic stenosis is one of such vascular heart disease. Aortic stenosis is a condition characterized by narrowing of hearts aortic valve, making it harder for blood to flow from the heart into the aorta and onward to the rest of the body. The Valvuloplasty Embossing Balloon is a novel device designed to relieve aortic stenosis by dilating the stenotic valve using a controlled inflation mechanism. This study presents an in-vitro simulation testing of a developed Valvuloplasty Embossing Balloon System and evaluates the performance of the balloon system. In-vitro simulation test is performed using aortic arch simulation model. Before progressing to clinical trials or further regulatory evaluation, this in-vitro test results helps to evaluate the Valvuloplasty Embossing Balloon performance. Research results demonstrate the efficacy and reliability of the proposed methodology, offering valuable insights for further development and optimization of the balloon system.