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Abbott’s new MitraClip G4 device approved by FDA

16th July 2019

Abbott’s MitraClip G4 heart valve repair device has been approved by the US Food and Drug Administration (FDA) for treatment of patients with mitral regurgitation.

MitraClip G4 is intended to repair leaky mitral valves without the need for open-heart surgery and the device is delivered to the heart via leg incision.

In order to minimize the blood backflow and restore heart’s ability to pump oxygenated blood, the device clips together the leaflet portions of the mitral valve.

The latest device contains new clip sizes and an improved leaflet grasping capability. It has independent controlled grippers to facilitate grasping of one or both leaflets.

Moreover, the upgraded catheter of the device enables continuous monitoring of left atrium pressure in real time during the implant procedure. This will help doctors to decide positioning of the device for improved patient outcomes.

The MitraClip system was initially launched by Abbott in Europe in 2008 and in the US in 2013. Till date, the device has been used to treat primary and secondary mitral regurgitation in more than 80,000 patients globally.

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