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In Brief: Perclose

This article was originally published in The Gray Sheet

Executive Summary

Perclose: Submits premarket approval application supplement to FDA for its Prostar Plus and Prostar XL next-generation surgical closure systems for arterial access sites. The submissions for the 8 Fr and 10 Fr Prostar Plus and 8 Fr Prostar XL follow the firm's April 30 PMA approval for the Prostar first-generation system ("The Gray Sheet" May 5, I&W-1). The supplement is supported by data from the 515-patient, seven-site Sutures to Ambulate and Discharge (STAND) II trial. Preliminary results disclosed in May indicated the Prostar Plus reduced the average length of patient hospitalization by 14% compared to conventional treatment ("The Gray Sheet" May 26, In Brief)...

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