Abbott has announced the first patient procedures using its investigational transcatheter aortic valve implantation (TAVI) balloon-expandable system for treating symptomatic severe aortic stenosis.
The first-in-human procedures were performed at the Republican Centre of Emergency Medicine in Tashkent, Uzbekistan, with Saidamir Djafarov as the site’s principal investigator.
According to Abbott, the investigational TAVI system is the first step toward a software-guided, balloon-expandable TAVI system and lays the foundation for artificial intelligence (AI)-guided procedures.
Once completed and approved by regulatory bodies, this system will expand Abbott’s structural heart portfolio.
It will offer physicians an additional TAVI management option alongside the commercially available Navitor TAVI system, which secured the US Food and Drug Administration (FDA) approval in January 2023.
Abbott structural heart business senior vice president Sandra Lesenfants said: “Abbott’s experience in the TAVI market gives us a unique understanding of the remaining unmet needs, and we’re applying this knowledge to develop future therapies to close that gap.
“By closely partnering with physicians on research into new innovations, we’re positioned to advance investigational therapies that have the potential to transform patient treatment.”
The investigational system is a balloon-expandable TAVI device that crimps a new heart valve onto a deflated balloon. The balloon with the mounted valve is inserted into the body via an artery in the groin and guided to the heart.
Once positioned within the narrowed heart valve, the balloon is inflated to expand the new valve, replacing the patient’s narrow native heart valve. Afterwards, the balloon is deflated and removed from the body.
Abbott stated that ongoing research and expansion of TAVI solutions are crucial as the needs of physicians and patients are evolving.
The company is said to have developed this differentiated TAVI platform by incorporating insights from physicians, leveraging advanced technology, and drawing on learnings from its TAVI product portfolio.
This platform aims to lay the groundwork for integrating AI-guided procedures, enhancing ease of use and precision, and delivering haemodynamic performance for optimal blood flow through the valve.
In September 2024, Edwards Lifesciences, another developer of TAVI systems, reported positive results from the RHEIA trial, which focused on evaluating outcomes for women undergoing TAVI.
