Ellipsys Medical expects its Ellipsys Vascular Access System, an ultrasound-guided device for creating arteriovenous (AV) fistulas in hemodialysis patients, to return to commercial availability with initial availability anticipated in mid-2026.
The Ellipsys System is a single-catheter device that uses ultrasound guidance to enable physicians to create an AV fistula percutaneously, without open surgery or a permanent implant. The procedure can be performed in a hospital, ambulatory surgery center, or office-based lab under local anesthesia, the firm said.
The system received clearance from the U.S. Food and Drug Administration (FDA) in 2018 and has been used in thousands of procedures worldwide, supported by peer-reviewed publications and multicenter studies, according to the company.
Ellipsys is planning a phased reintroduction including restoration of physician training programs and clinical education initiatives across the U.S. and select international markets.
