Ellipsys AV fistula system set for 2026 market return
The ultrasound-guided system is expected to return to commercial availability in mid-2026 for percutaneous AV fistula creation in hemodialysis patients.
Ellipsys Medical expects the Ellipsys Vascular Access System to return to commercial availability in mid-2026, according to a company announcement. The ultrasound-guided device is used to create arteriovenous fistulas in patients requiring hemodialysis access.
The system uses a single catheter to create an AV fistula percutaneously. The procedure can be performed under ultrasound guidance without open surgery or a permanent implant, according to Ellipsys Medical.
Physicians can perform the procedure in a hospital, ambulatory surgery center, or office-based lab under local anesthesia. The company said the planned return follows a period of limited market availability.
FDA records show that the Ellipsys Vascular Access System received 510(k) clearance under K183615. The device classification is listed as a percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access.
A 2018 pivotal multicenter trial enrolled 107 patients across 5 sites and evaluated ultrasound-guided anastomosis creation between the proximal radial artery and perforating vein. The study reported that the system met prespecified safety and efficacy endpoint goals.
Medtronic’s product information page describes Ellipsys as having a track record of more than 3,000 procedures across several settings. It also lists peer-reviewed publications comparing the system with surgical AV fistula creation.
The reintroduction is expected to include restoration of physician training programs and clinical education initiatives. Ellipsys Medical said the phased rollout will target the U.S. and select international markets.
Sources
- The pivotal multicenter trial of ultrasound-guided percutaneous arteriovenous fistula creation for hemodialysis access. Peer-reviewed study
- 510(k) Premarket Notification K183615. Regulatory filing
About the author
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Radiology Signal Staff covers developments across medical imaging, radiology AI, imaging informatics, clinical research, and radiology business. The team monitors primary sources, peer-reviewed studies, company announcements, society updates, and healthcare industry news to deliver concise reporting for imaging professionals.
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