All patients achieved technical success and 9/10 patients reached the secondary efficacy endpoint. Additionally, 9/10 patients achieved vein diameters exceeding the minimum national guideline of 6 mm needed to start hemodialysis. There were no serious adverse events related to the placement of the Optiflow?„?.
Dr. Ebner commented, "The Optiflow?„? provides a simple method for creating a precise and repeatable anastomosis. We are encouraged by the excellent flow and vein dilation." Dr. Roy-Chaudhury added, This data confirms the technical feasibility and safety of the Optiflow?„? device. The Optiflow?„? device could be an important adjunct for AVF maturation in the dialysis population, resulting in reduced costs and an improvement in patient care." Based on these favorable results, the Company is conducting a larger clinical study.
Note: The Optiflow is an investigational device and not available for commercial use in the United States.
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