Abbott Presents Late-Breaking Data for Navitor TAVR Device and Amplatzer Amulet LAA Occluder

February 28, 2023—Abbott announced late-breaking data for its next-generation Navitor transcatheter aortic valve replacement (TAVR) system and for the Amplatzer Amulet left atrial appendage (LAA) occluder.

According to the company, results from the PORTICO NG study supported Navitor’s FDA approval to treat patients with severe, symptomatic aortic stenosis who are at high or greater risk for open heart surgery, which Abbott announced on January 17, 2023.

Abbott stated that data from the Amplatzer Amulet investigational device exemption (IDE) trial demonstrated the benefits of the Amulet device’s immediate and complete closure of the LAA for patients with atrial fibrillation at risk of stroke.

The findings from both studies were presented during late-breaking presentations at CRT 2023, the Cardiovascular Research Technologies conference held February 25-28 in Washington, DC.

The prospective, multicenter, international, single-arm PORTICO NG trial found that the Navitor device, which features the NaviSeal active sealing cuff to reduce or eliminate paravalvular leak (PVL), is a safe and effective treatment option for patients with severe, symptomatic aortic stenosis who are at high or greater surgical risk.

Results presented at CRT include the following:

• 97% rate of procedural success
• 1.9% rate of all-cause mortality at 30 days
• 1.9% rate of disabling stroke at 30 days
• 0% moderate or greater PVL at 30 days, demonstrating effectiveness of the NaviSeal

“Abbott’s Navitor device offers a minimally invasive treatment option for severe aortic stenosis that can be lifesaving,” commented Michael Reardon, MD, the company’s press release. “The trial provides promising results on the safety and effectiveness of Navitor in addressing this common heart valve disease, highlighting a reduction in the backflow of blood around the valve due to the system's design.”

Dr. Reardon, who served as Principal Investigator for the PORTICO NG study of Navitor, is Alison Family Distinguished Chair of Cardiovascular Research and Professor of Cardiothoracic Surgery at the Houston Methodist Hospital in Houston, Texas.

The company noted that the Amulet IDE randomized trial is composed of more than 1,800 patients. The study’s findings demonstrated that the Amplatzer Amulet LAA occluder—which features dual-seal technology consisting of a lobe to fill the cavity of the LAA and a disc to seal off the opening into the LAA—had fewer unresolved, severe peridevice leaks (PDLs), compared to the Watchman device (Boston Scientific Corporation), which has a single component to close the LAA. PDLs after LAA occlusion have been shown to be associated with poor 5-year outcomes, including ischemic stroke or systemic embolism.

The new data from Amulet IDE trial presented at CRT demonstrated the following:

• Larger LAA anatomy was a predictor of severe PDL with the Watchman device whereas there were no anatomical predictors with the Amplatzer Amulet.
• Severe PDLs with the Amulet device were less common and resolved over time more often than with Watchman.
• Severe PDLs with Amulet were less commonly associated with adverse events and deaths than Watchman.