May 19, 2022 – Abbott announced two late-breaking data presentations highlighting both TriClip™, a first-of-its kind minimally invasive tricuspid heart valve repair device, and Navitor™, the company’s latest-generation transcatheter aortic valve implantation (TAVI) system. The company also showcased new data for MitraClip™ and Amplatzer™ Amulet™, two key components of the company’s industry-leading structural heart portfolio.
All data were presented at EuroPCR, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions, held in Paris from May 17-20, 2022.
New real-world outcomes highlighted in a late-breaking data presentation showed that the TriClip and TriClip G4 transcatheter edge-to-edge repair (TEER) systems significantly reduce tricuspid regurgitation (TR) and substantially improve quality of life across a wide range of anatomically diverse patients, with data through 30 days showing:
- High implant success rate (98%)
- Significant TR reduction (71% moderate or less compared to 3% as baseline) with a strong safety profile (99% freedom from major adverse events)
- Life-changing clinical improvements including 78% of patients achieving New York Heart Association (NYHA) Functional Class I/II (a classification of functional limitations resulting from cardiac disease), an improvement by 57% from baseline of 21%, and an 18-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (a self-assessment of social abilities, symptoms and quality of life)
Data from the multi-center, international, single arm study of the Navitor TAVI system with an active sealing cuff to minimize paravalvular leak (PVL) demonstrated improved one-year outcomes for patients with severe, symptomatic aortic stenosis who were at high or extreme surgical risk. Key findings include:
- High procedural success rate of 97.5%
- High rate of no/trace PVL (70.2%) and low rate of mild PVL (28.8%) through one year, indicating the active sealing cuff is effective in mitigating PVL
- Low rate of all-cause mortality (4.2%) at one year
- Single-digit gradients (average 7.5 mmHg) through one year
Other data sets presented at EuroPCR included positive findings from the EXPAND study which showed MitraClip therapy in heart failure patients with mitral regurgitation experience improved symptoms and quality of life. Additionally, although women have higher rates of early complications with LAA closure than men, results from the Amulet IDE trial found that both women and men implanted with Abbott’s Amplatzer Amulet Left Atrial Appendage (LAA) Occluder experienced similar long-term benefits from LAA closure.