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CE-mark for Baxter's mechanical heart valve:

This article was originally published in Clinica

Executive Summary

Baxter has CE-marked its bileaflet mechanical heart valve. The Edwards MIRA valve features a unique sewing ring and is suitable for a wide variety of surgical techniques, including minimally-invasive procedures. The company plans to begin clinical trials of the device in the US in 1998, pending approval of an investigational device exemption application by the FDA. Baxter estimated that over 250,000 patients worldwide undergo surgery every year to repair or replace diseased or defective heart valves.

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