Therapy Areas: Devices
Abbott wins US FDA approval of next-generation MitraClip under its leading MitraClip platform
16 July 2019 -

Healthcare company Abbott (NYSE:ABT) reported on Monday the receipt of approval from the US Food and Drug Administration (FDA) for the most advanced MitraClip heart valve repair device for the treatment of mitral regurgitation.

The company said its fourth-generation MitraClip device, MitraClip G4, puts new enhancements into the hands of physicians across the US by delivering an expanded range of clip sizes, an alternative leaflet grasping feature and facilitation of procedure assessment in real time to offer doctors further options when treating mitral valve disease.

According to the company, the MitraClip device repairs leaky mitral valves without open-heart surgery and is delivered to the heart through a small incision in the leg. The device clips portions of the leaflets, or flaps, of the mitral valve together to reduce the backflow of blood (known as mitral regurgitation, or MR), restoring the heart's ability to pump oxygenated blood more efficiently.

To date, MitraClip has helped treat 80,000 people worldwide suffering from both primary and secondary MR and is supported by the industry's most extensive body of clinical evidence, including the recent results of the landmark COAPT Trial published in The New England Journal of Medicine in September 2018, added the company.

Under an ongoing, patient-centric product development cadence, the company has expanded MitraClip to a total of four clip sizes, including clips with wider grasping area, to provide physicians additional options for treatment. MitraClip G4 offers independently controlled grippers that allow physicians to grasp one or both leaflets during the procedure.

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