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Edwards Lifesciences Secures Health Canada's Approval for PASCAL Precision Transcatheter Valve Repair System
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Edwards Lifesciences Secures Health Canada's Approval for PASCAL Precision Transcatheter Valve Repair System
Jul 12, 2024 9:27 AM

12:00 PM EDT, 07/12/2024 (MT Newswires) -- Edwards Lifesciences' ( EW ) Canadian unit said Friday that Health Canada approved its PASCAL Precision transcatheter valve repair system for the "percutaneous reduction of significant, symptomatic mitral regurgitation."

The company said data from the CLASP IID pivotal trial of the PASCAL Precision system demonstrated that the system achieved "significant and sustained" mitral regurgitation reduction in the first year.

Edwards Lifesciences ( EW ) (Canada) said the US Food & Drug Administration approved the PASCAL Precision system in 2022 for the treatment of degenerative mitral regurgitation.

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