September 21, 2020
Abbott’s MitraClip G4 Granted CE Mark in Europe to Treat Mitral Regurgitation
September 21, 2020—Abbott announced it has received European CE Mark approval for the fourth-generation MitraClip transcatheter mitral valve repair system, known as MitraClip G4.
The device is now approved for use in Europe and other countries that recognize CE Mark as a nonsurgical option for the treatment of mitral regurgitation (MR). The MitraClip G4 was approved for use in the United States in July 2019. It was approved in Japan in June 2020.
The MitraClip G4’s delivery system includes four clip sizes, including two wider clips, for a greater variety of treatment options that can be tailored to a patient’s unique mitral valve anatomy. Additionally, the new generation device has independently controlled grippers that allow physicians to grasp one or both mitral valve leaflets at a time during the MitraClip procedure.
Ralph Stephan Von Bardeleben, MD, head of the Heart Valve Center Mainz, Universitätsmedizin Mainz, Germany, treated the first patients with MitraClip G4 in the European Union.
Dr. Bardeleben commented in Abbott’s announcement, “Despite being consistently recognized as a problem in patients around the world, MR cannot be treated through the conventional method of open-heart mitral valve surgery in more than half of the people who have this condition. The newest MitraClip therapy offers physicians a reliable option when surgical treatment of MR isn’t possible or appropriate, and MitraClip G4’s enhancements allow further customization of the therapy to tailor treatment to individual patient needs.”
According to Abbott, data from a real-world clinical study of > 1,000 MitraClip patients showed a high implant success rate (99%) and demonstrated MR reduction to the level of none or trace in patients with either primary MR (to ≤ 1+ in 87.1%) or secondary MR (to ≤ 1+ in 90.1%) at 30 days. These recent data, which were presented at the virtual PCR e-Course held online June 25 to 27, 2020, add to a body of evidence that demonstrates a significant impact for patients, including improved clinical outcomes and quality of life.