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In Brief: Baxter

This article was originally published in The Gray Sheet

Executive Summary

Baxter: U.S. clinicals of the Edwards MIRA bileaflet mechanical heart valve are scheduled to begin in 1998, pending FDA approval of an investigational device exemption. The device, which received European CE mark approval on Dec. 9, features a new "sewing ring" design as well as technology from Baxter's Starr-Edwards silastic ball valve, and is "particularly suitable for a wide variety of surgical techniques, including...minimally invasive techniques," the company claims. The Edwards MIRA is manufactured by Fiat Group subsidiary Sorin Biomedica and will be marketed worldwide by Baxter under a 1996 agreement...

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