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TCT 2022: Edwards Ready To Take On Abbott In Mitral Repair Market With ‘Premium’ Device

 
• By Reed Miller

Edwards Lifesciences is ramping up US commercialization of its Pascal Precision mitral valve transcatheter edge-to-edge repair device, the first US competitor for Abbott’s MitraClip. The FDA approved Pascal Precision earlier than the company expected, based on results of the CLASP IID trial.

Edwards Lifesciences' Pascal M TEER clip
• Source: Edwards Lifesciences

Edwards Lifesciences is preparing to launch its Pascal Precision mitral valve transcatheter edge-to-edge repair (M-TEER) system in the US where it will be the first direct competitor for Abbott’s MitraClip.

Pascal Precision earned a CE mark in August and the US Food and Drug Administration approved it on 14 September. The new approval indicates Pascal Precision for the percutaneous reduction of significant, symptomatic mitral regurgitation (MR) in patients at prohibitive risk for mitral valve surgery

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