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FLEX Vascular's Promising 12-Month Study Results

FLEX Vascular, a Minnesota-based company, has made waves in the medical device community by announcing the results of a 12-month real-world study evaluating the FLEX™ Vessel Prep system. This innovative device focuses on patients experiencing dysfunctional access for hemodialysis. The findings were presented by Dr. Ari Kramer at the Charing Cross Symposium in London on April 21, 2026.

The study, known as the FLEX FIRST AV registry, involved 130 patients across four American centers and showcased a diverse and high-risk population, mirroring real clinical practice. The results reflect the high safety, durability, and efficiency of the FLEX™ Vessel Prep system, establishing it as a promising mechanical vascular preparation strategy.

Key Findings Over 12 Months

The results of the study were compelling, highlighting several significant outcomes:

• - Zero incidence of serious adverse events (SAEs) within 30 days, with only one minor complication (0.8%) reported.
• - 40% primary patency of the target lesion at 12 months in cephalic arch lesions, nearly doubling historical ATP benchmarks.
• - 100% secondary patency of AV grafts at 12 months, with no access abandonment.
• - The use of the FLEX™ system alongside PTA reduces the need for an average of one intervention per patient per year.

Dr. Kramer noted, "In a real-world population, we observed significant safety, fewer reinterventions, and promising durability, even in complex lesions like the cephalic arch."

Comprehensive Representation of Patients

The FLEX FIRST AV registry included patients with notable comorbidities, featuring 64.6% diabetics and 95.4% hypertensive individuals, with 60% of the subjects being African American. This diverse background enhances the applicability of the results in everyday clinical practice, emphasizing the need for effective solutions in various demographics.

A New Approach to Vessel Preparation

The FLEX™ Vessel Prep system employs a unique method called Kinetic Endovascular Micro-incision Creation (KEMIC) that creates micro-incisions within the blood vessels mechanically, without medication or implant use, optimizing vessel compliance before standard angioplasty.

Dr. Jordan Knepper, Chief Medical Officer of FLEX Vascular, shared his enthusiasm for the findings: "Together, these results herald a new paradigm in access intervention care, defined by enhanced safety, reduced reinterventions, and sustainable outcomes without added complexity."

About FLEX Vascular

Flex Vascular, part of VentureMed Group, Inc., is a pioneering private company dedicated to developing advanced endovascular solutions for arteriovenous access and peripheral vascular interventions. Its flagship product, the FLEX Vessel Prep™ System, is FDA 510(k) cleared and CE marked, designed to optimize vessel preparation using the proprietary KEMIC technology. The company's commitment is to innovation and transforming vascular access care continually.

For more information, please contact Tom Michals at [email protected] or call +1(763) 951-0280.