June 25, 2020
Abbott Announces New Data for its Structural Heart Device Portfolio
June 25, 2020—Abbott announced the presentation of late-breaking data at the virtual PCR e-Course held online June 25 to 27, including studies of its transcatheter devices for the treatment of mitral regurgitation (MR) and tricuspid regurgitation (TR).
Findings were presented on Abbott’s MitraClip system for transcatheter mitral valve repair system, the TriClip system for transcatheter tricuspid valve repair, and the Tendyne transcatheter mitral valve implantation system for mitral valve replacement. Additionally, data were reported from United States investigational device exemption (IDE) studies of the Amplatzer Amulet left atrial appendage occluder and the Portico system with FlexNav for transcatheter aortic valve replacement.
- MitraClip. Real-world outcomes from four separate analyses of the global EXPAND study showed that significant MR reduction (to ≤ 1+ in 87.1% of patients at 30 days for primary MR and 90.1% in patients with secondary MR) was consistently achieved with the company’s third-generation MitraClip NTR/XTR systems in patients with either primary or secondary MR. The real-world EXPAND study is composed of more than 1,000 patients who received the MitraClip NTR/XTR at 57 sites worldwide.
- Tendyne. Clinical outcomes from an analysis of 100 patients with symptomatic, moderate-to-severe or severe MR treated in the European clinical study of the Tendyne system demonstrated durability of MR elimination in 93.2% of patients and significant improvements in quality of life and functional capacity at 2 years. This study data support the valve as a safe treatment option that provides symptom relief and improved quality of life for people with symptomatic MR who are not eligible for open heart surgery or transcatheter mitral valve repair. In January 2020, the company announced European CE Mark approval of the Tendyne system.
- TriClip. Data from the TRILUMINATE CE Mark study evaluated the TriClip tricuspid valve repair device in 85 patients with TR at 21 sites in Europe and the United States. The 1-year follow-up data included sustained TR reduction in 87.1% of patients who received the device and an all-cause mortality rate of 7.1%. Sustained improvements in right heart function demonstrated the benefits of tricuspid valve treatment. The study met its primary safety and efficacy endpoints. The investigators concluded that TriClip is a safe and durable treatment option for high-risk patients with symptomatic moderate or greater TR. Abbott announced CE Mark approval for the TriClip device in April 2020.
- Amplatzer Amulet. The first analysis of 1-year clinical outcomes from the roll-in cohort of the Amplatzer Amulet IDE trial demonstrated an implant success rate of 99% and a procedural complication rate of 3.5%.
- Portico. Findings from the three studies supported the Portico system as a durable treatment option with excellent hemodynamic results and long-term performance for patients with severe aortic stenosis who are at high risk for open heart surgery. The new FlexNav delivery system was shown to provide an enhanced safety profile for the Portico device.