US-based health care company Abbott has secured the US Food and Drug Administration (FDA) approval for its advanced MitraClip heart valve repair device to treat mitral regurgitation.
Abbott has developed MitraClip G4 to as part of a patient-centric product development cadence, expanding MitraClip platform. MitraClip G4 marks the fourth generation MitraClip device, and its latest FDA approval is set to offer a next-generation approach to mitral valve repair.
MitraClip G4 features an expanded range of clip sizes, an alternative leaflet grasping feature and procedure assessment facility in real-time to provide physicians with additional options for treating mitral valve disease.
In addition, the device also offers independently controlled grippers for physicians to grasp one or both leaflets during the procedure, known as Controlled Gripper Actuation.
The latest generation of MitraClip is set to provide an upgraded catheter that allows integrated real-time continuous left atrial pressure monitoring during implant.
The pressure monitor integrated into the MitraClip catheter continuously monitors and confirms MR reduction during the implant procedure and helps in determining the optimal position of MitraClip.
Abbott structural heart business chief medical officer Neil Moat said: “We are continually innovating the MitraClip technology based on the experience of the physicians implanting the device so we can truly help them improve the lives of their patients.
“With the fourth generation of MitraClip, we set out to build a system that would help physicians individualize the therapy to each patient and deliver even more features that can treat both primary and secondary mitral regurgitation.”
Abbott said that its MitraClip system, commercially available in the US since 2013 and in Europe since 2008, marks the first and only transcatheter mitral valve therapy with proven safety and survival, and durable clinical outcomes.
In 2013, MitraClip was approved in the US for primary MR patients, and in March 2019 US FDA has approved the device for secondary MR patients based on results from the COAPT trial.
The COAPT Trial that investigated MitraClip for treating secondary MR, showed a 47% relative reduction in hospitalizations and a 38% relative reduction in mortality.
Abbott has been developing MitraClip platform since the initial approval, by introducing newer generations G2, G3 and now G4, to support patient care.