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Abbott reports positive data on heart valve therapies

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TriClip transcatheter tricuspid valve repair system Abbott
The TriClip transcatheter tricuspid valve repair system [Image courtesy of Abbott]
Abbott (NYSE:ABT) today announced clinical study data supporting its TriClip and Navitor heart valve treatment technologies.

Data for the TriClip minimally invasive tricuspid heart valve repair device and Navitor next-generation transcatheter aortic valve implantation (TAVI) system were presented at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR).

Real-world outcomes from the bRIGHT study, a 30-day evaluation of the TriClip and TriClip G4 transcatheter edge-to-edge repair (TEER) systems, showed that they significantly reduced tricuspid regurgitation (TR) and substantially improved quality of life across a range of anatomically diverse patients, according to a news release.

TriClip had a high implant success rate (98%) with a strong safety profile (99% freedom from major adverse events). The trial showed that 78% of patients achieved New York Heart Association (NYHA) Functional Class I/II (a classification of functional limitations resulting from cardiac disease), an improvement by 57% from a baseline of 21%.

Abbott also reported an 18-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (a self-assessment of social abilities, symptoms and quality of life).

One-year data from a multi-center, international, single-arm study of the Navitor TAVI system with an active sealing cuff to minimize paravalvular leak (PVL) demonstrated improved outcomes in patients with severe, symptomatic aortic stenosis who were at high or extreme surgical risk.

Procedural success rate came in at 97.5%, with a high rate of no/trace PVL (70.2%) and a low rate of mild PVL (28.8%) through one year, which Abbott said demonstrates the effectiveness of the active sealing cuff in mitigating PVL. All-cause mortality was low (4.2%).

Both TriClip and Navitor are approved for investigational use only in the U.S. Abbott Park, Illinois–based Abbott also showcased data for its MitraClip and Amplatzer Amulet systems.

The Expand study showed that MitraClip improved symptoms and quality of life in heart failure patients with mitral regurgitation. Although women have higher rates of early complications with left atrial appendage (LAA) closure than men, Abbott said, results from an FDA investigational device exemption (IDE) trial showed that both women and men implanted with the Amplatzer Amulet LAA occluder experienced similar long-term benefits.

“At Abbott, we’re dedicated to delivering innovative technologies to help people with debilitating heart conditions live better lives through better health,” SVP of Abbott’s structural heart business Michael Dale said in the release. “The data presented during this year’s EuroPCR meeting underscore our unwavering commitment to providing structural heart solutions, supported by clinical evidence, that surpass existing standards of care.”

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