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.
The Ellipsys System, previously available in the United States and internationally, provides a percutaneous approach to creating an arteriovenous (AV) fistula for patients requiring hemodialysis access. Its return restores access to a technology that many clinicians have continued to seek as interest in less invasive approaches to creating vascular access grows.
“We are excited to restore access to Ellipsys for clinicians who have continued to advocate for minimally invasive fistula creation,” said Brian Driscoll, CEO of Ellipsys Medical. “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.”
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.
“For patients living with kidney failure, every procedure has a meaningful impact on their daily lives,” said Terry Litchfield, MPA, CPC, President, Access Solutions. “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.”
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.
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 Ellipsys System enables physicians to create a percutaneous AV fistula using a single catheter under ultrasound guidance. The procedure can be performed in multiple care settings and is designed to reduce the need for surgical incisions, implants, and vessel manipulation.