Abbott Releases Late-Breaking Data for Minimally Invasive Heart Devices

Abbott Labs released late-breaking data for its next-gen Navitor transcatheter aortic valve implantation (TAVI) system. Study results supported Navitor’s recent FDA approval for people with severe, symptomatic aortic stenosis at high or greater risk for open-heart surgery.
 
The company also featured late-breaking data for its Amplatzer Amulet left atrial appendage (LAA) occluder, which continues to highlight the device’s benefits of immediate and complete LAA closure.
 
Results were presented at the annual Cardiovascular Research Technologies (CRT) meeting.
 
In the PORTICO NG study, Navitor was found to offer:

• High rate of procedural success (97%)
• Low rate of all-cause mortality (1.9%) and disabling stroke (1.9%) at 30 days
• Excellent PVL results, including 0% moderate or greater PVL at 30 days, demonstrating effectiveness of the NaviSeal active sealing cuff

 
“Abbott’s Navitor device offers a minimally invasive treatment option for severe aortic stenosis that can be lifesaving,” Michael Reardon, M.D., Alison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital, who served as principal investigator for the study that led to FDA approval of Navitor, told the press. “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.”
 
For the Amplatzer Amulet IDE study (compared to Boston Scientific’s Watchman device), new data demonstrated:

• 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

 
“These results for Navitor and Amulet demonstrate that the innovative designs of our minimally invasive devices are changing how doctors are approaching—and patients are experiencing—the treatment of structural heart conditions,” said Michael Dale, senior VP of Abbott’s structural heart business. “We continue to focus on addressing the unmet needs of patients with heart disease and advancing standards of care so people can live their fullest possible lives.”