Abbott’s Next Generation MitraClip G4 Demonstrates Improved Quality of Life in Clinical Trial

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Abbott (NYSE: ABT) today announced data from a global clinical trial of its MitraClip G4 for the treatment of mitral valve regurgitation (MR).

MitraClip G4, the fourth generation of Abbott’s MitraClip devices, demonstrated MR reduction to ≤1 + in the vast majority (91%) of patients and significantly improved New York Heart Association (NYHA) class and quality of life in the Expand G4 study, according to a press release.

The study also showed that the MitraClip G4 tailored therapy to patient needs and improved procedural efficiency while ensuring consistent MR reduction and safety.

The Expand G4 aimed to evaluate current clinical outcomes in the field in patients treated with the next generation MitraClip G4. The multi-center, single-arm study will enroll up to 1,100 symptomatic primary and secondary MR patients in the United States, Europe, Canada, and Japan.

The most important endpoints include procedural results (acute procedural success as survival until discharge with an MR reduction to ≤ 2+), the severity of the MR and the occurrence of serious adverse events after 30 days, as well as the assessment of the data by an independent echocardiographic core laboratory. The study population currently includes 529 enrolled subjects who received a MitraClip implant and 343 subjects who were followed up for 30 days.

Abbott’s MitraClip G4, headquartered in Abbott Park, Ill., Is available in four clip sizes, each with the option to independently grasp the brochure (controlled gripper actuation) and an improved clip deployment sequence, the company said in its presentation.

“The Expand G4 study shows that MitraClip G4 allows therapy to be tailored to patients’ needs; improves procedural efficiency while maintaining MR reduction and safety in a real, contemporary environment, ”concluded the company.


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