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MEDTRONIC FREESTYLE STENTLESS PORCINE VALVE APPROVABLE RECOMMENDATION COVERS THREE IMPLANTATION TECHNIQUES; MD TRAINING, POSTMARKET STUDY STRESSED

This article was originally published in The Gray Sheet

Executive Summary

Medtronic's Freestyle stentless porcine valve was endorsed for approval by FDA's Circulatory System Devices Panel with three implantation methods at a Sept. 15 meeting. The advisory panel voted unanimously for approval of the device with caveats pertaining to physician training and postmarket evaluation. The panel agreed that the Freestyle could be implanted with subcoronary, full root, and root inclusion implantation techniques. St. Jude's stentless Toronto SPV, which the panel recommended for approval on Sept. 16, can be implanted only with the subcoronary method.
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