Abbott
(NYSE: ABT)
today reported positive study data supporting its first-generation transcatheter aortic valve system and its Amplatzer Amulet.
Abbott reported its outcomes at the Cardiovascular Research Technologies (CRT) 2024 meeting.
The company first reported a pooled analysis from three clinical studies evaluating its Portico TAVR system, the predecessor to Navitor. It showed the safety and effectiveness of Portico for severe, symptomatic aortic stenosis in patients at high and extreme surgical risk through five years.
Abbott reported excellent sustained blood flow and prevention of paravalvular leaks (PVLs) with Portico. It also reported favorable clinical event rates at a high rate of accurate valve matching due to the wide range of annulus size.
The company also had data on the Navitor system, which maintained safety and effectiveness through one year. Abbott’s investigational device exemption (IDE) study for the valve found that it continues to offer a safe and effective option for patients with symptomatic, severe aortic stenosis at high and extreme surgical risk.
Navitor’s active sealing cuff technology led to the prevention of mild or less PVLs at a 99.5% rate. The valve also produced excellent sustained blood flow and kept safety rates low through one year.
Finally, a post-approval study of the Amplatzer Amulet device highlighted its safety and effectiveness. It looked at patients who had the left atrial appendage occluder (LAAO) implanted between August 2021 and June 2023. They were enrolled in the U.S. National Cardiovascular Data Registry (NCDR) LAAO Registry.
The study focused on the learning curve and peri-procedural outcomes. Results included a high acute implant success rate above 97% and improved outcomes with more experience with the device. Abbott also reported a high degree of closure (more than 96.5%) regardless of operator experience.