Abbott Announces First Step Toward Its Software-Guided Balloon-Expandable TAVI System to Treat Aortic Stenosis
Abbott (NYSE: ABT) announced its first patient procedures using an investigational transcatheter aortic valve implantation (TAVI) balloon-expandable system for treating severe aortic stenosis. This system represents the initial phase toward developing a software-guided TAVI system with AI capabilities. The technology will complement Abbott's existing Navitor™ TAVI system, offering physicians additional options for patient treatment.
The balloon-expandable device works by crimping a new heart valve on a deflated balloon, which is inserted through a leg artery and guided to the heart. The balloon is then inflated to expand the valve, replacing the function of the narrowed native valve.
Abbott (NYSE: ABT) ha annunciato le prime procedure sui pazienti utilizzando un sistema di impianto di valvola aortica transcatetere (TAVI) espandibile con palloncino per il trattamento della stenosi aortica severa. Questo sistema rappresenta la fase iniziale per sviluppare un sistema TAVI guidato da software con capacità di intelligenza artificiale. La tecnologia completerà l'esistente Navitor™ TAVI system di Abbott, offrendo ai medici opzioni aggiuntive per il trattamento dei pazienti.
Il dispositivo espandibile con palloncino funziona comprimendo una nuova valvola cardiaca su un palloncino sgonfio, che viene inserito attraverso un'arteria della gamba e guidato fino al cuore. Il palloncino viene quindi gonfiato per espandere la valvola, sostituendo la funzione della valvola nativa ridotta.
Abbott (NYSE: ABT) anunció sus primeros procedimientos en pacientes utilizando un sistema de implantación de válvula aórtica transcatéter (TAVI) expandible por balón para el tratamiento de la estenosis aórtica severa. Este sistema representa la fase inicial hacia el desarrollo de un sistema TAVI guiado por software con capacidades de inteligencia artificial. La tecnología complementará el Navitor™ TAVI system existente de Abbott, ofreciendo a los médicos opciones adicionales para el tratamiento de los pacientes.
El dispositivo expandible por balón funciona al comprimir una nueva válvula cardíaca en un balón desinflado, que se inserta a través de una arteria en la pierna y se guía hasta el corazón. Luego, el balón se infla para expandir la válvula, reemplazando la función de la válvula nativa estrechada.
애보트 (NYSE: ABT)는 중증 대동맥 협착증 치료를 위한 경방식 대동맥 판막 이식(TAVI) 풍선 확장 시스템을 사용하여 첫 번째 환자 시술을 발표했습니다. 이 시스템은 인공지능 기능을 갖춘 소프트웨어 기반 TAVI 시스템 개발을 위한 초기 단계입니다. 이 기술은 애보트의 기존 Navitor™ TAVI system을 보완하여 의사에게 환자 치료를 위한 추가 옵션을 제공합니다.
풍선 확장 장치는 새 심장 판막을 부풀리지 않은 풍선에 압착하여 작동하며, 이 풍선은 다리 동맥을 통해 삽입되어 심장까지 안내됩니다. 그런 다음 풍선이 팽창하여 판막을 늘리며, 좁아진 본래 판막의 기능을 대체합니다.
Abbott (NYSE: ABT) a annoncé ses premières procédures sur des patients utilisant un système d'implantation valvulaire aortique par cathéter (TAVI) compressible par ballon pour traiter des sténoses aortiques sévères. Ce système représente la phase initiale vers le développement d'un système TAVI guidé par logiciel avec des capacités d'intelligence artificielle. La technologie complétera le Navitor™ TAVI system existant d'Abbott, offrant aux médecins des options supplémentaires pour le traitement des patients.
Le dispositif à balon compressible fonctionne en comprimant une nouvelle valve cardiaque sur un ballon dégonflé, qui est inséré par l'artère de la jambe et guidé jusqu'au cœur. Le ballon est ensuite gonflé pour expanser la valve, remplaçant ainsi la fonction de la valve native rétrécie.
Abbott (NYSE: ABT) kündigte seine ersten Patientenverfahren mit einem experimentellen transkatheter aortalen Klappenimplantationssystem (TAVI) an, das mit einem aufblasbaren Ballon zur Behandlung schwerer Aortenstenose arbeitet. Dieses System stellt die erste Phase zur Entwicklung eines softwaregesteuerten TAVI-Systems mit KI-Funktionalität dar. Die Technologie wird das bestehende Navitor™ TAVI system von Abbott ergänzen und den Ärzten zusätzliche Optionen zur Patientenbehandlung bieten.
Das ballonexpandierbare Gerät funktioniert, indem es ein neues Herzklappenventil auf einen deflated balloon komprimiert, das durch eine Beinarterie eingeführt und zum Herzen geleitet wird. Der Ballon wird dann aufgeblasen, um das Ventil zu erweitern und die Funktion des verengten einheimischen Ventils zu ersetzen.
- Development of new AI-guided TAVI system expanding Abbott's structural heart portfolio
- Addresses growing market with ~9% prevalence in adults over 80 years
- Successful completion of first-in-human procedures
- System still in investigational phase requiring clinical development and regulatory approval
- Faces existing competition in the TAVI market
Insights
This development represents Abbott's strategic expansion in the TAVI market, introducing a software-guided balloon-expandable system that lays groundwork for AI integration. The investigational system's design focuses on three key improvements: enhanced blood flow performance, increased procedural precision and improved ease of use.
The market opportunity is substantial, with
The successful first-in-human procedures mark an important milestone, but investors should note that full commercialization remains distant pending clinical trials and regulatory approvals. This positions Abbott competitively in the $5 billion global TAVI market, particularly against Edwards Lifesciences and Medtronic.
- The investigational transcatheter aortic valve implantation (TAVI) system will complement Abbott's Navitor™ TAVI system for aortic stenosis, a common and life-threatening heart valve disease
- The investigational system is designed to offer best-in-class heart blood flow, ease of use and precision
- Approximately
9% of older Americans have aortic stenosis1
ABBOTT PARK, Ill., Nov. 25, 2024 /PRNewswire/ -- 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
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.
"Transcatheter aortic valve implantation treatment has benefitted both physicians and patients over the years, but physicians have come to understand one device does not fit all their patients with aortic stenosis," said Azeem Latib, M.D., section head and director of interventional cardiology and director of structural heart interventions at Montefiore Health System, who conducted the first procedures with the device alongside cardiac surgeon, Vinayak Bapat, M.D., chair of cardiothoracic surgery at the Minneapolis Heart Institute. "We, and hospitals worldwide, remain focused on helping this growing patient population by investigating and providing expanded treatment options that adapt to the unique needs and anatomies of patients."
Continued research and expansion of TAVI solutions is necessary for the industry as the needs of physicians and patients evolve. Leveraging insights from physicians, the latest technology advancements and key learnings from the company's TAVI product portfolio, Abbott has developed this differentiated TAVI platform with the objective of building a foundation for the incorporation of AI-guided procedural capabilities. The goal is to enhance ease of use and precision, while offering best-in-class hemodynamic performance, or blood flow through the valve.
"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," said Sandra Lesenfants, senior vice president of Abbott's structural heart business. "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 first-in-human procedures were successfully conducted at the Republican Centre of Emergency Medicine in
For
About Abbott
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1 Iung B, Vahanian A. Epidemiology of valvular heart disease in the adult. Nat Rev Cardiol. 2011;8:162-72.
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