Abbott (NYSE:ABT) today publicized data from a global clinical trial of its MitraClip G4 for treating mitral 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 trial, according to a news brief.
The study also demonstrated that the MitraClip G4 tailors therapy to patients’ needs and improves procedural efficiency while maintaining consistent MR reduction and safety.
Expand G4 aimed to evaluate contemporary real-world clinical outcomes in patients treated with the next-generation MitraClip G4. The multi-center, single-arm study seeks to enroll up to 1,100 symptomatic primary and secondary MR patients in the U.S., Europe, Canada and Japan.
Key outcomes include procedural outcomes (acute procedural success as survival to discharge with MR reduction to ≤ 2+), MR severity and occurrence of major adverse events at 30 days and data adjudication to an independent echocardiographic core laboratory. The study population at present includes 529 subjects enrolled who underwent MitraClip implantation and 343 subjects with 30-day follow-up.
Abbott Park, Illinois’ based Abbott’s MitraClip G4 comes in four clip sizes. At the same time, each comes with the option for independent leaflet grasping (controlled gripper actuation) and improved clip deployment sequence, the company said in its presentation.
“The Expand G4 study demonstrates that MitraClip G4 enables tailoring the therapy to patients’ needs; improves procedural efficiency while maintaining consistent MR reduction and safety in a real-world contemporary setting,” the company concluded.