A new case report published in the Journal of Vascular Surgery (JVS) provides one of the first known opportunities to directly visualise the anastomosis that is created with Avenu Medical’s Ellipsys vascular access system, a press release reveals.
“This is the first published report of direct visualisation of a matured pAVF [percutaneous arteriovenous fistula] created with the Ellipsys System,” said lead author Alexandros Mallios (Paris Saint-Joseph Hospital, Paris, France). “It was an amazing opportunity that provided first hand proof of the permanent, fused vessel anastomosis made possible by this revolutionary technology.”
The subject of the case report was an 80-year-old male diabetic end-stage renal disease (ESRD) patient who had a pAVF created with the Ellipsys system six months prior. He was evaluated for decreasing blood flow (unrelated to his fistula) and required surgical intervention, which provided the opportunity to visualise the matured Ellipsys pAVF up close. According to Mallios, the lack of sutures or other foreign bodies made the fusion look “remarkably natural.”
Mallios has published numerous studies showing the ability of the Ellipsys system to easily and safely create durable vascular access for ESRD patients. In July 2020, he reported one-year follow-up results of 234 Ellipsys patients. Published in JVS, the study reported no adverse events and 96 percent of patients still had fully functioning fistulas with strong blood flow after a year. That “patency rate” is higher than published rates for surgically created fistulas, which average about 60% after one year.
In April 2020, JVS published a case report by Mallios that featured a 3D rendering of the Ellipsys pAVF on the cover of the publication. Mallios also co-authored two recent papers in the Journal of Vascular Access that discussed patient eligibility for Ellipsys and the similarities between an Ellipsys pAVF and a surgical AVF, the current standard of care.
Recently published long-term Ellipsys data showed a functional patency rate of 92% at two years. The study also found high levels of patient satisfaction with the procedure.
Medtronic recently announced its plan to acquire Avenu Medical for the Ellipsys percutaneous fistula creation technology. Terms of the deal were not disclosed.