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KENSEY NASH ANGIO-SEAL AND DATASCOPE VASOSEAL ARE APPROVABLE, FDA ADVISORY PANEL CONCLUDES; WARNINGS ABOUT HIGH RISK GROUPS MUST BE IN LABELING

This article was originally published in The Gray Sheet

Executive Summary

Kensey Nash's Angio-Seal and Datascope's VasoSeal hemostasis devices should have warnings in labeling about the lack of clinical data supporting their safety and efficacy in high risk patients, FDA's Circulatory Systems Devices Panel recommended at its May 8 meeting in Gaithersburg, Maryland.

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