**Abbott, a prominent entity in global healthcare, has declared the initial patient operations utilizing its experimental balloon-expandable transcatheter aortic valve implantation (TAVI) system for managing severe, symptomatic aortic stenosis.** This investigational system is a preliminary phase towards Abbott’s envisioned software-directed balloon-expandable TAVI system, setting the stage for procedures guided by artificial intelligence (AI). Following the conclusion of clinical trials and regulatory approval, Abbott’s structural heart offerings will incorporate an alternative TAVI solution for physicians, alongside the already available Navitor TAVI system.
The aortic valve is critical for controlling the movement of oxygenated blood throughout the body. As individuals age, calcium might accumulate, leading to narrowing, or aortic stenosis, which forces the heart to exert additional effort to push blood through. This condition, if unattended, can manifest in symptoms like chest discomfort, breathlessness, and fainting, potentially weakening the heart and posing serious health threats. For patients facing risks with open-heart surgery due to factors such as age, fragility, or comorbidities, minimally invasive procedures offer promising alternatives, introducing devices through leg arteries. Aortic stenosis is notably the most prevalent primary valve ailment, with its frequency escalating with age—affecting about 2% of individuals aged 70-80 and rising to 9% for those aged over 80.
The investigational system exemplifies a balloon-expandable TAVI device, wherein the new valve is constricted onto a deflated balloon. This balloon-valve combo is introduced via an artery at the groin and directed to the heart. Upon reaching the correct location within the narrowed native valve, the balloon inflates, allowing the new valve to assume its role. Following expansion, the balloon deflates and is extracted.
“Over the years, transcatheter aortic valve implantation has proved beneficial for medical professionals and patients alike, yet experience has shown no singular device suits every patient with aortic stenosis,” commented Azeem Latib, M.D., section head for interventional cardiology at Montefiore Health System. Dr. Latib, together with Vinayak Bapat, M.D., chairing the cardiothoracic surgery at Minneapolis Heart Institute, led the inaugural procedures with this device. “Our focus and that of hospitals globally remain on aiding this expanding patient group by developing and delivering varied treatment options that accommodate the unique needs and anatomical characteristics of patients.”
To align with the evolving requirements of physicians and patients, continued research and the enhancement of TAVI solutions are necessary. Abbott harnesses insights from medical experts, the latest technological progress, and learnings from their existing TAVI products to differentiate this new platform. Their objective: to create an infrastructure for AI-enhanced procedural techniques, striving for improved usability and accuracy while delivering top-tier hemodynamic performance.
“Abbott’s long-standing foothold in the TAVI sector grants us insight into unmet needs, and we are channeling this understanding into crafting future treatments to address these gaps,” said Sandra Lesenfants, senior vice president with Abbott’s structural heart division. “Our close collaboration with physicians in pioneering research enables us to push the envelope in investigational therapies, potentially revolutionizing patient care.”
The initial human procedures were executed successfully at the Republican Centre of Emergency Medicine in Tashkent, Uzbekistan, alongside team lead investigator, interventional cardiologist Saidamir Djafarov, M.D.
Abbott continues its mission as a global healthcare front-runner, fostering improved living across life’s stages. Its diverse array of transformative technologies cuts across diagnostics, medical devices, nutritionals, and branded generic medicines.