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September 19, 2022

Abbott reports late-breaking data supporting use of structural heart devices

The data demonstrated the benefits of Abbott's MitraClip for treating mitral regurgitation, TriClip for tricuspid regurgitation.

Abbott has reported data from five late-breaking presentations demonstrating the advantages of its minimally invasive devices that are designed to treat people with various structural heart diseases.

The new data of the company’s minimally invasive structural heart technologies were presented at the 34th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific meeting of the Cardiovascular Research Foundation in Boston.

It includes results that strengthen the effectiveness and safety of the transcatheter edge-to-edge repair (TEER) device, MitraClip, in treating the leaking valves in mitral regurgitation (MR) patients.

Data from the multi-centre, prospective, worldwide real-world EXPAND G4 trial backed the safety and efficacy of the MitraClip G4 system to treat MR.

With more than 1,000 participants, the study’s findings show that MitraClip has success rates for reducing MR, improving the quality of life, with less adverse event rates.

At 30 days, significant reduction in MR to mild or less is observed in 91% of patients, with 83% of patients achieving New York Heart Association (NYHA) Functional Class I/II.

The findings have also showed the benefits of the company’s TriClip, the first therapy which is specifically designed for tricuspid heart valve repair.

The randomised, controlled TRILUMINATE Pivotal trial is designed to assess the TEER’s safety and efficacy with TriClip in 700 patients with severe TR in Europe, Canada, and the US.

After 30 days, the findings from the roll-in cohort indicated a high implant success rate of 99% and one-grade TR reduction in 91% of patients, with moderate or less residual TR achieved in 74% of them.

Abbott has also reported results of its minimally invasive device, Amplatzer Amulet Left Atrial Appendage Occluder, designed for complete closure of the left atrial appendage (LAA) for reducing the stroke risk.

The findings from the multicentre, prospective, international Amulet IDE trial includes data from over 1,800 patients, and three-year outcomes that show Amplatzer Amulet’s safety and effectiveness.

Additionally, Abbott reported data from the multi-centre, randomised, prospective, controlled PREDICT-LAA trial, which studied whether the use of FEops HEARTguide, cardiac computed tomography-based computational models, help in the planning of Amplatzer Amulet procedures.

At three months, planning with HEARTguide for high-resolution heart scans resulted in improved procedural efficiency and safety outcomes with the Amplatzer Amulet LAA Occluder.

Furthermore, the company announced data from the prospective, real-world global CONFIDENCE Registry study that evaluated the safety and effectiveness of Portico, a self-expanding transcatheter aortic valve implantation (TAVI) system.

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