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FDA Dispute Resolution Panel To Review CardioGenesis PMR Data In August

This article was originally published in The Gray Sheet

Executive Summary

CardioGenesis will rely on data previously reviewed by FDA in seeking to overturn an initial "not approvable" determination by the agency for its PMR percutaneous myocardial revascularization system

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PMR back to the drawing board

CardioGenesis will not seek an FDA Medical Devices Dispute Resolution Panel review, following an unapprovable determination by the agency on the firm's PMA supplement for percutaneous myocardial revascularization (PMR). Further clinical work to gain approval will be considered during a future meeting with FDA, the company says. CardioGenesis cancelled an August 2003 dispute resolution panel review in an attempt to reconcile its clinical data directly with the agency (1"The Gray Sheet" June 2, 2003, p. 6). While CardioGenesis has not completely abandoned the notion of a future dispute panel review, the firm will focus on securing approval in Europe, Canada and Australia. CardioGenesis shares plummeted 29% on the news, closing at $0.74 on March 25...

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