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An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure

Arkansas · Jonesboro, AR

The purpose of this early feasibility study is to evaluate the safety and feasibility of the device for percutaneous shunting of the interatrial septum and improvement of heart failure related symptoms. The primary goal is to determine if the device is safe to use. The findings from this study may be used to refine the intended patient population, the design of the device, or develop a subsequent randomized study.