Kidney Week

Abstract: TH-PO1287

A Decellularized Biological Vascular Graft for Hemodialysis Access: 18-Month First-in-Human Clinical Outcomes of LineMatrix

Session Information

• Late-Breaking Research Posters
  October 22, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Dialysis

• 803 Dialysis: Vascular Access

Authors

• Xuefeng, Qiu, Huazhong University of Science and Technology Tongji Medical College, Wuhan, Hubei, China

Qiu Xuefeng, MD

• Guo, Ying, Humatrix Medical Technology (Suzhou) Co., Ltd, Suzhou, Jiangsu, China

Ying Guo, RN

• Ye, Hong, Department of Nephrology, The Second Affiliated Hospital of Nanjing Medical University, Suzhou, Jiangsu, China

Hong Ye, MD

• Luo, Yuan, Department of Nephrology, The Second Affiliated Hospital of Nanjing Medical University, Suzhou, Jiangsu, China

Yuan Luo, MD

• Chen, Shuangshuang, Humatrix Medical Technology (Suzhou) Co., Ltd, Suzhou, Jiangsu, China

Shuangshuang Chen, PhD

• Li, Hua, Zhejiang University School of Medicine Sir Run Run Shaw Hospital, Hangzhou, Zhejiang, China

Hua Li, MD

Background

Arteriovenous grafts (AVGs) are an important vascular access option for hemodialysis patients. Conventional ePTFE grafts have limitations including infection risk and limited patency. LineMatrix^® is a decellularized bovine carotid artery graft developed as a biologic alternative. This first-in-human study evaluated its safety and performance.

Methods

This prospective, single-arm study (ChiCTR2500106717) enrolled 12 patients with end-stage kidney disease requiring hemodialysis. LineMatrix^® grafts were implanted in the upper extremity and used for routine hemodialysis. Primary endpoint was primary patency at 3 months. Safety and patency outcomes were assessed through 18 months.

Results

Twelve LineMatrix^® grafts were successfully implanted. Two patients were excluded due to non-device-related infection at day 29 and withdrawal of consent at day 89. Among the per-protocol population (n=10), primary patency rates at 3, 6, 12, and 18 months were 90.0%, 80.0%, 70.0%, and 46.7%, respectively. Five patients required a total of 12 interventions to maintain patency (corresponding to 0.72 interventions/patient-year). Cumulative patency was maintained at 100% throughout 18 months. Freedom from LineMatrix^®-related infection remained 100% at 18 months despite repeated hemodialysis cannulation (2-3 cannulations/week; estimated cumulative cannulation number: 149-234). No device-related steal syndrome, cardiac complications, aneurysm, pseudoaneurysm, or seroma were observed.

Conclusion

LineMatrix® demonstrated favorable safety outcomes and durable cumulative patency through 18 months. A multicenter randomized controlled trial comparing LineMatrix® with ePTFE grafts is ongoing to further evaluate clinical outcomes (ChiCTR2500107160; n=326).

Acknowledgment

Commercial Support – Humatrix Medical Technology (Suzhou) Co., Ltd.

Figure 1. LineMatrix^® graft implantation and clinical outcomes.
(A) Implantation of LineMatrix^® graft. (B) LineMatrix^® AVG after 18 months. (C) Doppler ultrasound measurements at 12-month follow-up. (D) Digital subtraction angiography (DSA) at the 3-month follow-up. (E) Primary and cumulative patency rates of LineMatrix^® grafts in the PPS over 18 months follow-up.

Funding

• Private Foundation Support