If the now RDGL EFS IDE results in an approved Supplemental for an FDA Authorized Pivotol Trial or a Traditional FS to take place it can take years to complete.
“A traditional feasibility study is a clinical investigation that is commonly used to capture preliminary safety and effectiveness information on a near-final or final device design to adequately plan an appropriate pivotal study. Because the study of a near-final or final device design takes place later in development than an early feasibility study, FDA would expect to see more nonclinical (or prior clinical) data in a traditional feasibility study IDE application. A traditional feasibility study does not necessarily need to be preceded by an early feasibility study. A pivotal study is a clinical investigation designed to collect definitive evidence of the safety and effectiveness of a device for a specified intended use, typically in a statistically justified number of subjects. It may or may not be preceded by an early and/or a traditional feasibility study.”
“an analysis of pivotal trials on medical devices conducted between 2006 and 2013, the median duration was three years, with another two years needed for FDA review and approval for marketing.[3] In 2017 in the United States, the median cost of a pivotal trial across all clinical indications was US$19 million.”
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