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FLEX Vascular Unveils Impressive Long-Term Efficacy of FLEX™ Vessel Prep System

FLEX Vascular, a Minneapolis-based medical device company, has announced the successful results from the 12-month mark of the FLEX FIRST AV Registry, a study representing real-world data. This clinical research aims to evaluate the performance of their FLEX™ Vessel Prep System specifically designed for patients with dysfunctional vascular access for hemodialysis.

The study showcased its findings at the Charing Cross Symposium in London on April 21, 2026, presented by Dr. Ari Kramer, a prominent figure in vascular access at the Spartanburg Regional Medical Center in South Carolina. It included data from 130 patients across four U.S. centers, providing a comprehensive insight into the device's safety, durability, and effectiveness in a high-risk population typical of everyday clinical settings.

Key Findings at the 12-Month Mark

1. 0% Rate of Major Adverse Events: Within the first 30 days post-intervention, none of the patients experienced severe complications, with only 0.8% reporting minor issues.
2. Improved Target Lesion Primary Patency Rate: The primary patency of target lesions in patients showed a remarkable rate of 40% at 12 months, particularly in cases involving the cephalic arch, which nearly doubles historical benchmarks tied to traditional percutaneous transluminal angioplasty (PTA).
3. Unprecedented Secondary Patency Rates: Impressively, the study found a 100% secondary patency rate in arteriovenous grafts after 12 months, with no access points abandoned.
4. Fewer Procedures Needed: Utilizing the FLEX™ system in conjunction with PTA led to an average reduction of one intervention per patient per year, reflecting potential savings and reduced burden on healthcare systems.

Dr. Kramer stated, "These findings indicate a profound change in how we approach arteriovenous access interventions. We are observing a notable safety profile, fewer additional procedures, and encouraging durability, even in challenging cases like cephalic arch lesions."

Real-World Evidence and Diverse Patient Population

The patient cohort included individuals with significant comorbidities, showcasing the real-world applicability of the results. Notably, 64.6% of those studied had diabetes, while 95.4% were diagnosed with hypertension. Additionally, 60% of the participants were African American, thus illustrating the broad relevance of these findings across various demographics critical to daily clinical practice.

Innovative Approach to Vascular Preparation

The FLEX™ Vessel Prep System incorporates Kinetic Endovascular Microincision Technique (KEMIC), a groundbreaking method that eschews drugs and implants. It is geared towards optimizing vascular adaptability ahead of standard angioplasty procedures, potentially revolutionizing the current practices in vascular access interventions.

Dr. Jordan Knepper, FLEX Vascular's Chief Medical Officer, concluded, "Together, these findings endorse a transformative care paradigm in vascular access interventions characterized by enhanced safety, decreased number of reinterventions, and long-lasting outcomes without added complexity."

About FLEX Vascular

FLEX Vascular, incorporated under VentureMed Group, Inc., thrives as a pioneering enterprise in the medical devices realm, focusing on endovascular solutions for arteriovenous access and peripheral vascular interventions. Their flagship product, the FLEX Vessel Prep™ system, is a FDA-approved and CE-marked device renowned for its unique KEMIC technology, designed to refine the preparation of blood vessels effectively.

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Tom Michals
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