LONDON, April 23, 2026

In a significant advancement for vascular access treatment, FLEX Vascular has announced 12-month real-world outcomes demonstrating enhanced safety, durability, and reduced reinterventions using its FLEX™ Vessel Prep System. The findings, presented at the Charing Cross Symposium, highlight a potential paradigm shift in treating dysfunctional hemodialysis access, especially in complex patient populations. The study underscores how innovative mechanical vessel preparation technologies may outperform traditional approaches such as standard angioplasty, offering clinicians a more reliable and efficient solution for long-term vascular access management.

Strong Clinical Outcomes in Real-World Study

The FLEX FIRST AV Registry, a prospective multi-center study, evaluated 130 high-risk patients across four U.S. centers, reflecting real-world clinical practice conditions. Presented by Dr. Ari Kramer, the results revealed 0% serious adverse events (SAEs) at 30 days and only a 0.8% minor complication rate, indicating a remarkable safety profile. Importantly, the study demonstrated 40% target lesion primary patency (TLPP) at 12 months in cephalic arch lesions—nearly double traditional PTA benchmarks—while AV grafts maintained 100% secondary patency, with no cases of access abandonment.

These findings are particularly critical given the challenges associated with maintaining long-term vascular access in dialysis patients, where repeated interventions often lead to increased costs and complications. The data further revealed that using FLEX technology resulted in the elimination of approximately one intervention per patient per year, significantly improving both patient outcomes and healthcare efficiency.

Innovative Technology Driving Better Outcomes

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At the core of this advancement is the Kinetic Endovascular Micro-Incision Creation (KEMIC) technology, a drug-free and implant-free mechanical approach designed to enhance vessel compliance before angioplasty. Unlike conventional methods that rely heavily on balloon dilation alone, the FLEX™ system creates controlled micro-incisions, enabling more uniform vessel expansion and reduced trauma.

According to Dr. Jordan Knepper, this approach represents a new standard in vessel preparation, combining simplicity with improved clinical performance. By eliminating the need for additional implants or drug-coated devices, the technology reduces procedural complexity while maintaining consistent and durable results, making it highly suitable for widespread adoption in diverse healthcare settings.

Real-World Relevance and Future Impact

The registry included a diverse patient population, with 64.6% diagnosed with diabetes and 95.4% with hypertension, reflecting the true burden of comorbidities in dialysis patients. Additionally, 60% of participants were African American, emphasizing the broad applicability and inclusivity of the findings. This diversity strengthens the study’s relevance, as it mirrors everyday clinical scenarios rather than controlled trial environments.

Experts believe these results could lead to revised treatment protocols for arteriovenous (AV) access interventions, prioritizing mechanical vessel preparation strategies over traditional methods. With healthcare systems increasingly focusing on cost reduction, patient safety, and long-term outcomes, the FLEX™ Vessel Prep System offers a compelling solution that aligns with modern clinical and economic goals. The findings signal a shift toward more efficient, patient-centered vascular care, potentially reducing the burden on both patients and healthcare providers worldwide.

Source: FLEX Vessel Prep press release