FLEX reports 12-month AV access data for vessel prep system
Bottom line
FLEX Vascular said it presented 12-month real-world data at the Charing Cross Symposium 2026 for its FLEX Vessel Prep System, a device used before angioplasty in dysfunctional hemodialysis access. In the company’s prospective, multicenter FLEX FIRST AV Registry, 130 patients were enrolled across four U.S. centers. FLEX reported 0% serious adverse events at 30 days, one minor complication, 40% target lesion primary patency at 12 months in cephalic arch lesions, and 100% secondary patency in AV grafts with no access abandonment. The presentation was delivered April 21, 2026, in London by Ari Kramer, MD, according to the company, and follows earlier six-month registry data presented at CX in 2025. (prnewswire.com)
Why it matters: While this is a human medtech update rather than a veterinary-specific development, it’s relevant to veterinary professionals who track interventional device trends because it reflects continued industry interest in vessel preparation strategies that aim to improve angioplasty durability without adding a drug or permanent implant. FLEX’s system is FDA 510(k)-cleared for use with PTA catheters, and the company is positioning the 12-month registry results around fewer repeat interventions, a value proposition that matters in any setting where reintervention burden, procedural time, and access preservation are important. The key caveat is that these results come from a company announcement about a registry presentation, not a peer-reviewed publication, so clinicians should watch for fuller data, comparator details, and independent validation before drawing broader conclusions. (prnewswire.com)
What to watch: Watch for a full manuscript, additional subgroup analyses, and whether FLEX seeks broader adoption based on registry data beyond conference presentations. (prnewswire.com)
FLEX Vascular used the Charing Cross Symposium 2026 to spotlight 12-month real-world outcomes for its FLEX Vessel Prep System in dysfunctional hemodialysis access, framing the data around safety, durability, and fewer repeat procedures. According to the company’s April 23 announcement, the findings came from the FLEX FIRST AV Registry, a prospective, multicenter study of 130 patients treated at four U.S. centers, with results presented in London on April 21 by Ari Kramer, MD, chair of the vascular access program at Spartanburg Regional Medical Center. (prnewswire.com)
The update builds on six-month registry data that FLEX, then operating under VentureMed Group branding, presented at the same meeting in April 2025. That earlier readout described the same 130-patient observational registry in hemodialysis patients with arteriovenous fistulas or grafts and positioned the technology as a vessel-preparation step before standard angioplasty. The device itself received FDA 510(k) clearance in 2020 for use with percutaneous transluminal angioplasty catheters in stenotic peripheral arteries, including AV access lesions, giving the company a regulatory foothold before it began expanding its clinical evidence base. (prnewswire.com)
In the new 12-month release, FLEX said the registry showed 0% serious adverse events at 30 days and a single minor complication, or 0.8%. The company also highlighted 40% target lesion primary patency at 12 months in cephalic arch lesions and 100% secondary patency in AV grafts, with no access abandonment. FLEX further said the results translated to the elimination of one intervention per patient per year on average when the system was used with PTA. The enrolled population was described as clinically complex, including high rates of diabetes and hypertension, and 60% of patients were African American. (prnewswire.com)
The technology is built around what FLEX calls Kinetic Endovascular Micro-Incision Creation, or KEMIC, a mechanical approach intended to improve vessel compliance before angioplasty without a drug coating or implanted scaffold. On its clinical materials pages, the company says the platform is being developed and promoted across both AV access and peripheral vascular use cases, with registry, retrospective, and peer-reviewed evidence forming the backbone of its commercial messaging. That positioning is consistent with a broader endovascular trend toward lesion preparation strategies meant to improve angioplasty performance while avoiding some of the tradeoffs associated with more complex adjunctive devices. (flexvascular.com)
Outside commentary was limited, but Vascular News previewed the CX 2026 vascular access session and identified the FLEX FIRST 12-month dataset as one of several first-time presentations aimed at testing whether promising clinical trial concepts hold up in real-world practice. In the company release, Kramer said the findings suggest a meaningful shift in AV access intervention, while chief medical officer Jordan Knepper, MD, said the data support a care model centered on improved safety, fewer reinterventions, and durable outcomes. Those comments should be read in context: they come from stakeholders closely tied to the product, and no independent expert reaction or peer-reviewed manuscript was readily available at the time of writing. (vascularnews.com)
Why it matters: For veterinary professionals, this story is less about immediate clinical application and more about where interventional medicine is heading. Human vascular access technologies often signal broader device-development themes, including the push toward mechanical vessel preparation, lower reintervention rates, and workflow-friendly tools that can be paired with standard angioplasty. Even so, the evidence here remains early in the sense that it is conference-stage and company-reported. Without a full publication, it is difficult to assess lesion selection, comparator methodology, operator variability, and how much of the reported benefit is attributable to the device versus case mix or procedural technique. (prnewswire.com)
That distinction matters because registry data can be clinically useful, especially in high-risk, real-world populations, but it doesn’t settle questions about comparative effectiveness. For clinicians and industry watchers, the most important next step is independent scrutiny of the dataset, including whether the cephalic arch and AV graft outcomes hold up under peer review and whether reductions in reintervention can be reproduced across centers beyond early adopters. If those findings are confirmed, FLEX could strengthen its case that vessel prep is not just an adjunctive step, but a meaningful strategy for preserving access and reducing repeat procedures. (prnewswire.com)
What to watch: Watch for a peer-reviewed publication, additional comparative analyses versus historical PTA outcomes, and any future commercial or regulatory moves that extend FLEX’s evidence story beyond conference presentations and company materials. (prnewswire.com)