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San Clemente Today
By the People, for the People
Ellipsys Vascular Access System to Return to U.S. Market in 2026
Proven percutaneous AV fistula technology set to re-enter the market with phased rollout in 2026
Apr. 2, 2026 at 12:40pm
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Ellipsys Medical, Inc. today announced that the Ellipsys® Vascular Access System will once again be commercially available, with initial availability anticipated in mid-2026. The announcement marks the planned reintroduction of the minimally invasive technology to clinicians and patients following a period of limited market availability.
Why it matters
The return of Ellipsys comes amid continued momentum toward less-invasive treatment options in vascular access, as clinicians and health systems seek approaches that improve patient comfort, streamline workflows, and support long-term access durability.
The details
The Ellipsys System is an ultrasound-guided, single-catheter device that enables physicians to create an AV fistula without open surgery or a permanent implant. The procedure can be performed in a hospital, ambulatory surgery center, or office-based lab, typically using local anesthesia. Since receiving FDA clearance in 2018, the system has been used in thousands of procedures worldwide and has been supported by peer-reviewed publications, multicenter studies, and real-world clinical experience demonstrating high maturation rates and durable outcomes.
- Ellipsys System received FDA clearance in 2018.
- Ellipsys System will be commercially available again starting in mid-2026.
The players
Ellipsys Medical, Inc.
A medical device company that developed the Ellipsys Vascular Access System, a minimally invasive technology for creating arteriovenous (AV) fistulas for hemodialysis patients.
Brian Driscoll
The CEO of Ellipsys Medical, Inc.
Terry Litchfield
The President of Access Solutions, an organization that supports patients living with kidney failure.
What they’re saying
“We are excited to restore access to Ellipsys for clinicians who have continued to advocate for minimally invasive fistula creation. The system has a strong clinical foundation, and its return reflects both the demand we've heard from the field and our commitment to expanding vascular access options.”
— Brian Driscoll, CEO, Ellipsys Medical, Inc.
“For patients living with kidney failure, every procedure has a meaningful impact on their daily lives. By offering a minimally invasive option that avoids open surgery and supports reliable dialysis access, Ellipsys can help reduce the burden of care and improve the patient experience.”
— Terry Litchfield, President, Access Solutions
What’s next
Ellipsys Medical plans a phased reintroduction of the system, including the restoration of physician training programs, clinical education initiatives, and customer support infrastructure across the United States and select international markets.
The takeaway
The return of the Ellipsys Vascular Access System to the U.S. market in 2026 represents a significant development in the ongoing shift towards less-invasive treatment options for patients requiring hemodialysis access. This minimally invasive technology can help improve patient comfort, streamline clinical workflows, and support long-term access durability, ultimately enhancing the overall patient experience.
