Abbott’s Investigational TAVI System for Aortic Stenosis Used in Its First Surgery

Abbott 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 first-in-human procedures were successfully conducted at the Republican Centre of Emergency Medicine in Tashkent, Uzbekistan, in collaboration with site principal investigator, interventional cardiologist Saidamir Djafarov, M.D.

“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 investigational system is a type of balloon-expandable TAVI device that works by crimping the new heart valve on a deflated balloon. The balloon with the mounted valve is 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.

Continued research and the expansion of TAVI solutions are necessary for the industry as the needs of physicians and patients evolve. The goal of Abbotts’ TAVI solutions is to enhance ease of use and precision while offering best-in-class hemodynamic performance or blood flow through the valve.

“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