November 9, 2020
6-Month Data Presented From FIH Study of Surmodics’ Avess AV Fistula DCB
November 9, 2020—Surmodics, Inc. announced that 6-month data from the AVESS first-in-human study of the company’s Avess arteriovenous (AV) fistula drug-coated balloon (DCB) was shared at VIVA 2020, the Vascular InterVentional Advances annual meeting held as a virtual congress November 6-8, 2020.
The AVESS study is a prospective, multicenter, single-arm study to assess the safety and performance of the Avess DCB when used in the treatment of patients with obstructive lesions of AV fistula for hemodialysis. The Avess DCB is an investigational device, limited by United States law to investigational use.
According to the company, the 6-month data from the study show that target lesion patency at 30 days and 6 months was 100% and 90.9%, respectively. A single reintervention was required within 6 months, with no AVFs thrombosed. The study’s primary safety endpoints reported no mortality and no device- or procedure-related adverse events at 30 days, and all patients maintained functional AVFs for hemodialysis.
The 6-month data include results from 12 patients treated with an Avess DCB between December 2018 and August 2019. The majority of AVFs were radiocephalic (10/12, 83.3%) with the stenosis located in the juxta-anastomosis (7/12, 58.3%), cannulation zone (2/12, 16.7%), and outflow (3/12, 25%). All patients completed follow-up at or beyond 6 months.
Ramon L. Varcoe, MD, and Andrew Holden, MD, are co-lead investigators for the AVESS FIH clinical trial. Dr. Varcoe is Associate Professor of Vascular Surgery at Prince of Wales Hospital in Sydney, New South Wales, Australia. Dr. Holden is Associate Professor and Director of Interventional Radiology at Auckland City Hospital in Auckland, New Zealand.
In the company’s press release, Dr. Varcoe stated, “This first-in-human study demonstrates that the Avess DCB is a safe and promising treatment for AV fistula stenosis, which can lead to vascular access dysfunction, thrombosis, and loss.
“Previous AV fistula studies have demonstrated that DCBs effectively reduce rates of restenosis after percutaneous angioplasty. The Avess DCB is a next-generation DCB that may provide further clinical benefits while minimizing systemic paclitaxel exposure.”