Abbott (NYSE:ABT) today announced the first patient procedures with its investigational transcatheter aortic valve implantation (TAVI) balloon-expandable system for treating symptomatic severe aortic stenosis. This investigational Abbott TAVI system is the first step toward Abbott's software-guided balloon-expandable TAVI system and is designed to build a foundation for artificial intelligence (AI) guided procedures. Once the investigational balloon-expandable system completes clinical development and is approved by regulatory authorities, Abbott's structural heart portfolio will offer physicians another TAVI management option to meet the patient's needs along with the company's Navitor TAVI system, which is already commercially available.

The aortic valve is a heart valve that controls the flow of oxygen-rich blood to the body. With age, calcium may build up in the valve and cause it to narrow – a condition known as aortic stenosis – resulting in the heart needing to work harder to pump blood through the valve. Left untreated, aortic stenosis can cause symptoms, such as chest pain, shortness of breath and fainting, and it can weaken the heart and become life-threatening. Patients who are at risk of open-heart surgery due to age, frailty or having multiple other conditions may benefit from minimally invasive treatment options where a device is delivered to the heart through an artery in the leg. Aortic stenosis remains the most common primary valve disease and its prevalence increases with age, ranging from approximately 2% in adults 70-80 years of age to 9% in adults older than 80 years.1

The investigational system is a type of balloon-expandable TAVI device, which works by crimping the new heart valve on a deflated balloon. The balloon with the mounted valve is then inserted into the body through an artery in the groin and routed up to the heart. Once properly positioned inside the narrowed heart valve, the balloon is inflated to expand the new valve, taking over the function of the patient's narrow native heart valve. The balloon is then deflated and removed from the body.