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Edwards Lifesciences' Sapien

This article was originally published in The Gray Sheet

Executive Summary

Transcatheter pulmonic heart valve gains CE-mark approval in Europe, the firm announces May 26. The device is intended as an alternative to surgical valve replacement for patients with congenital disease of the pulmonic valve, the company says. Placement is achieved using Edwards' RetroFlex 3 transfemoral delivery system. In the U.S., the valve is being studied in the firm's COMPASSION trial to support an eventual Humanitarian Device Exemption
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