Abbott Receives EU Approval for Fourth-Generation MitraClip G4 Device
Abbott Laboratories has obtained CE Mark approval for its fourth-generation MitraClip G4 device, enabling its use throughout the European Union. The system is designed to repair leaking mitral valves without open-heart surgery.
Abbott Laboratories announced it has received CE Mark approval for its fourth-generation MitraClip G4 Transcatheter Mitral Valve Repair System. This approval allows the device to be used across the European Union to treat patients with mitral regurgitation, commonly known as a leaky mitral valve.
The MitraClip G4 system had previously received U.S. Food and Drug Administration (FDA) approval in 2019. Abbott also reported expanded use of the device globally, including its introduction in China and new approvals in Japan during the summer.
Abbott states that the MitraClip device has been used to treat over 100,000 people worldwide with leaking mitral valves. The fourth-generation MitraClip G4 offers physicians a wider range of clip sizes, allowing for repairs tailored to individual patient anatomy. It also features new leaflet grasping technology designed to optimize clip placement and ensure leaflet insertion.
The MitraClip system provides a minimally invasive alternative to open-heart surgery for select patients. Clinical data, including results from the COAPT trial, has demonstrated the device's effectiveness in reducing hospitalizations and improving quality of life for patients with mitral regurgitation and heart failure.