The US pivotal trial's major safety and efficacy outcome goals were met by the Ellipsys Vascular Access System. In the important multicenter trial of percutaneous arteriovenous fistula formation under ultrasound guidance.
107 participants were included in a 5-site prospective single-arm experiment. The Ellipsys Vascular Access System (Avenu Medical, Inc., San Juan Capistrano, California) was used on patients to create an major safety and efficacy anastomosis between the proximal radial artery and perforating vein under ultrasound (US) guidance, which was followed by separate efficacy operations. The brachial artery flow volume 500 mL/min, the target vein diameter 4 mm, and the lack of device-related problems at 90 days were the primary objectives.
Keep yourself and others safe by avoiding harm or risk. That entails using caution to avoid tripping, slamming into, or colliding with objects. It is called major safety.
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