Abbott says study backs Amplatzer Amulet against Watchman FLX

Left atrial appendage occlusion (LAAO) devices.
Marketed left atrial appendage occlusion (LAAO) devices include Abbott’s Amplatzer Amulet (left) and Boston Scientific’s Watchman (right). [Images courtesy of Abbott and Boston Scientific]

Abbott’s (NYSE:ABT) today presented data supporting the use of its Amplatzer Amulet against Boston Scientific’s (NYSE:BSX) competing device.

According to a press release, device-related factors and all-cause deaths represented categories that favored Amplatzer Amulet over Watchman.

Abbott has developed its Amplatzer Amulet left atrial appendage (LAA) occluder with dual-seal technology. It has a lobe or piece to fill the cavity of the LAA and a disc to close the opening into the LAA. The company said it is the first and only minimally invasive treatment option that offers immediate and complete closure of the LAA with double sealing. It reduces the risk of stroke and eliminates the need for blood-thinning medication.

The prospective, international, multi-center Amulet IDE study is the largest randomized LAA occlusion study to date, Abbott said. It included more than 1,800 patients.

Abbott reported three-year results showing that patients with Watchman were more likely to have had device-related thrombosis or device leaks before stroke compared to patients with Amulet. In addition, the company said that cardiovascular and all-cause death trends were higher for the Watchman device than for the Amulet device.

Data from last year’s TCT showed that Boston Scientific’s next-generation stroke prevention device Watchman FLX outperformed the Amulet device. The results of the single-center, retrospective SEAL FLX study with 300 Danish patients showed that Watchman FLX was superior in the areas of LAA occlusion and peri-device leakage.

More amulet data

Abbott also presented data from its PREDICT-LAA study. The prospective, multi-center, randomized, controlled study evaluated the planning process of Amplatzer’s amulet procedures.

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The study looked at the use of cardiac computed tomography-based computational models – high-resolution heart scans created by FEops HEARTguide. It was evaluated whether these scans help in planning Amplatzer amulet procedures.

Results demonstrated improved procedural efficiency and safety outcomes associated with HEARTguide planning.

Abbott TriClip works well

Abbott presented initial results from the pivotal TRILUMINATE study at TCT 2022. It is the company’s first randomized, controlled study evaluating the safety and efficacy of TEER with TriClip. The study evaluated 700 patients with severe tricuspid regurgitation (TR). Patients spanned the US, Canada and Europe.

The 30-day roll-in cohort results showed a high implantation success rate of 99%. The study also observed a TR reduction of at least one level in 91% of patients. In addition, 74% of patients achieved moderate or less residual TR.

The patients achieved an improvement of approximately 17 points in the KCCQ score. The 30 percent improvement from baseline indicates a “significant improvement” in quality of life.

There’s more to come

Abbott will present data from its CONFIDENCE registry on Sunday. The international, prospective field study evaluates the safety and effectiveness of Portico TAVI (transcatheter aortic valve implantation).

The study used the first generation Portico delivery system in 501 patients and the second generation FlexNav system in 500 patients.