Elixir Medical Announces FDA Approval to Commence EXCELLA III Clinical Trial with DESyne® Nx Novolimus Eluting Coronary Stent System in the United States
5/8/2013 11:06:04 AM
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SUNNYVALE, Calif--(BUSINESS WIRE)--Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced today that it has received approval from the Food and Drug Administration (FDA) to initiate patient enrollment in the EXCELLA III clinical trial in the United States at up to 50 institutions with conditions to be addressed in parallel. Results from the EXCELLA III pivotal trial will be used to support a future Pre-Market Approval (PMA) application in the US for the DESyne® Nx Novolimus Eluting Coronary Stent System.
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