Abbott’s Software-Guided TAVI/TAVR System Used in First-in-Human Procedures

December 2, 2024—Abbott recently announced the first patient procedures with its investigational transcatheter aortic valve implantation/replacement (TAVI/TAVR) balloon-expandable system for treating symptomatic severe aortic stenosis.

According to the company, the investigational device is the first step toward commercializing Abbott’s software-guided balloon-expandable TAVI system. After the system completes clinical development and receives approval by regulatory authorities, the device will join Abbott’s structural heart portfolio that includes the Navitor TAVI/TAVR system, which is commercially available.

The company advised that the first-in-human procedures with the device were conducted by interventional cardiologist Azeem Latib, MD, alongside cardiac surgeon Vinayak Bapat, MD, at the Republican Center of Emergency Medicine in Tashkent, Uzbekistan, in collaboration with the site principal investigator, interventional cardiologist Saidamir Djafarov, MD.

Dr. Latib is section head and director of interventional cardiology and director of structural heart interventions at Montefiore Health System in New York, New York. Dr. Bapat is Chair of Cardiothoracic Surgery at the Minneapolis Heart Institute in Minneapolis, Minnesota.

Abbott stated that by leveraging insights from physicians, the latest technology advancements, and key learnings from the company’s TAVI product portfolio, it has developed this differentiated TAVI platform to build 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.

“TAVI 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,” commented Dr. Latib in Abbott’s press release. “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.”