Results from the Navitor study supported recent FDA approval for the transcatheter aortic valve implantation (TAVI) system. The FDA last month approved the system for treating severe, symptomatic aortic stenosis in those at high or greater risk for open-heart surgery.
Data also demonstrated the benefits of the Amplatzer Amulet left atrial appendage (LAA) occluder, according to a news release. It offers immediate and complete closure of the LAA for patients with AFib at risk of stroke.
Abbott presented both studies at the annual Cardiovascular Research Technologies (CRT) meeting in Washington, D.C.
The findings reinforce the importance of continued advancements in minimally invasive technology that offer hope to patients with debilitating heart conditions,” the company said.
Results for the next-gen Abbott Navitor TAVI system
After developing the latest version of the Navitor system, Abbott launched its Portico NG study. The prospective, multi-center, international, single-arm trial supported last month’s FDA approval.
The study’s results presented Navitor as a safe and effective treatment for aortic stenosis. It demonstrated a high rate of procedural success (97%). The implant also showed a low rate of all-cause mortality and disabling stroke (both 1.9%) at 30 days.
Navitor also features an active sealing cuff for reducing or eliminating blood backflow around the valve (paravalvular leak, or PVL). PVL results showed 0% moderate or greater PVL at 30 days, Abbott said.
Dr. Michael Reardo, principal investigator, said Navitor represents a treatment option “that can be lifesaving.” Reardon also serves as Alison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital.
“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,” he added.
Amplatzer Amulet results
Abbott said its Amulet IDE trial is the largest LAA occlusion study to date with more than 1,800 patients. Findings demonstrated that the device with dual-seal technology had fewer unresolved, severe peri-device leaks (PDLs) compared to Boston Scientific’s previous-generation Watchman device. Dual-seal technology features a lobe or piece to fill the LAA cavity and a disc to seal off the opening. PDLs occur when blood leaks around the implant.
Larger LAA anatomy proved to be a predictor of severe PDL with Watchman, while Abbott said no anatomical predictors registered with Amulet. Abbott also reported that. PDLs were less common with Amulet and resolved more over time. They were also less commonly associated with adverse events and deaths.
“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, SVP 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.”
The study marks the latest head-to-head data reveal between Amulet and Watchman devices. In September 2022, Abbott reported that device-related factors and all-cause death represented categories favoring Amplatzer Amulet against Watchman. Data from TCT 2021 demonstrated that the next-generation Watchman FLX stroke prevention device outperformed the Amulet device.
Good heart valve news for Abbott follows negative Trifecta news
Just yesterday, the FDA published a letter to healthcare providers warning that the company’s Trifecta family of heart valves could deteriorate early.
Published literature indicated a higher cumulative incidence of early structural valve deterioration (SVD) for Trifecta valves compared to other commercially available valves. In this instance, early is defined as five years.
The Trifecta valves treat diseased, damaged, or malfunctioning native or prosthetic aortic heart valves.
