Ellipsys Vascular Access System to Return to Market

April 2, 2026—Ellipsys Medical, Inc. announced that the Ellipsys vascular access system will re-enter the market, with commercial availability of the device anticipated in mid-2026.

Previously available in the United States and international markets, the Ellipsys system is an ultrasound-guided, single-catheter device that allows a percutaneous approach to create an arteriovenous fistula (AVF) in patients requiring hemodialysis access.

Ellipsys Medical stated it 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 received FDA clearance in 2018 and is supported by peer-reviewed publications, multicenter studies, and real-world clinical experience, noted the company.

Terry Litchfield, President, Access Solutions, a provider of patient advocacy consulting services within the dialysis industry, commented in the Ellipsys Medical press release, “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.”

Brian Driscoll, CEO of Ellipsys Medical, stated in the company’s press release, “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.”

As previously reported in Endovascular Today, the Ellipsys system was developed by Avenu Medical, which was acquired by Medtronic in 2020. Medtronic discontinued the device in 2025 in the company’s refocus of products and treatment areas, including its exit from the fistula creation market.

In comments to Endovascular Today, a representative from Medtronic advised, "Medtronic has finalized an agreement to sell the Ellipsys vascular access system for AVF creation to Ellipsys Medical Inc., a new company founded by leaders who have deep expertise in this space. When we made the difficult decision to discontinue the commercialization of Ellipsys in 2025, we explored every option to limit the impact on patients and customers. We are pleased that Ellipsys Medical, Inc. will continue to provide Ellipsys as an innovative, minimally invasive alternative to surgical fistula creation. Together, we are committed to a smooth transition for our customers and patients.”

Medtronic noted its continued commitment to the arteriovenous market with products including the In.Pact AV drug-coated balloon and the Fortrex HP percutaneous transluminal angioplasty balloon catheter.