Abbott Presents Studies of Portico, Navitor, and Amplatzer Amulet Devices

March 12, 2024—At CRT 2024, the Cardiovascular Research Technologies annual meeting held March 9-12 in Washington, DC, Abbott presented findings from studies of three of the company’s devices for cardiac interventions: the Portico transcatheter aortic valve replacement (TAVR) system, the Navitor TAVR device, and the Amplatzer Amulet left atrial appendage occluder (LAAO).

According to the company, Rishi Puri, MD, delivered data from a pooled analysis of three clinical studies that demonstrated that the company’s first-generation Portico device (the predecessor to Navitor) is a safe and effective treatment for severe, symptomatic aortic stenosis in patients at high and extreme surgical risk through 5 years.

The findings included excellent sustained blood flow and prevention of paravalvular leaks (PVLs) and favorable clinical event rates and a high rate of accurate valve matching attributed to the device’s wide range of annulus sizes.

Also at CRT 2024, Paul Mahoney, MD, presented 1-year data from the prospective, multicenter, international, single-arm Navitor investigational device exemption (IDE) study.

The Navitor IDE showed that Abbott’s Navitor TAVR system continues to serve as a safe and effective option for patients with symptomatic, severe aortic stenosis at high and extreme surgical risk. Among the key findings were the prevention of mild or less PVLs (99.5%) attributed to Navitor’s active sealing cuff technology; excellent sustained blood flow from an intra-annular, self-expanding valve; and low safety event rates through 1 year.

Finally, Atman P. Shah, MD, presented findings from the EMERGE LAA real-world postapproval study of the Amplatzer Amulet LAAO. Investigators evaluated the safety and effectiveness of the Amplatzer Amulet device implanted in patients between August 2021 and June 2023 who were enrolled in the United States National Cardiovascular Data Registry LAAO Registry. They focused on the learning curve and periprocedural outcomes with the device.

The analysis showed a high acute implant success (> 97%) and improved outcomes as more experience was gained with the device. Additionally, there was a high degree of closure (> 96.5%), regardless of operator experience, immediately after implantation in all experience categories, reported the company.