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Societies Gain FDA Go-Ahead, Medicare Coverage To Study New Access Methods For Edward’s Sapien Valve

This article was originally published in The Gray Sheet

Executive Summary

It’s the first time Society of Thoracic Surgeons and American College of Cardiology have ever filed for an investigational device exemption. The goal of the effort is to gain reimbursement for an expanded set of procedures with Sapien to make the device accessible to more patients.

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