#USA #Minneapolis #FLEX Vessel Prep #Flex Vascular #KEMIC technology

Introduction

Minneapolis's FLEX Vascular has made waves in the medical field with an exciting presentation unveiling 12-month outcomes from their FLEX FIRST AV Registry. This prospective, multi-center study aims to evaluate the effectiveness of the FLEX™ Vessel Prep System in patients suffering from dysfunctional hemodialysis access. Presented by Dr. Ari Kramer at the Charing Cross Symposium in London, these results highlight the system's safety and performance characteristics that could redefine vascular access interventions.

Study Overview

The FLEX FIRST AV Registry involved 130 patients across four medical centers in the United States, showcasing a diverse cohort that simulates real-world clinical settings. The participants, categorized in a high-risk population, included significant comorbidities such as diabetes and hypertension—64.6% and 95.4%, respectively. Remarkably, 60% of the patients also identified as African American, further ensuring that the findings have broad applicability.

Key Findings

The results shared were nothing short of compelling:

• - Safety: The study reported 0% serious adverse events (SAEs) within the first 30 days, with only one minor complication recorded (0.8%). This statistic is particularly significant, suggesting that the FLEX Vessel Prep System is a safe option for patients at high risk.
• - Durability: The target lesion primary patency (TLPP) at the 12-month mark for cephalic arch lesions reached an impressive 40%, nearly doubling historical benchmarks for percutaneous transluminal angioplasty (PTA).
• - Performance: The findings evoked an exciting 100% secondary patency in AV grafts after one year without any cases of access abandonment. Notably, utilizing the FLEX system with PTA resulted in the reduction of one intervention per patient per year on average, indicating a significant positive shift in patient care.

Dr. Kramer aptly stated, "These results suggest a meaningful shift in how we approach AV access interventions," reinforcing that the FLEX Vessel Prep System stands out even in the face of complex lesions such as those in the cephalic arch.

Innovative Technology

The FLEX™ Vessel Prep System employs a unique approach known as Kinetic Endovascular Micro-Incision Creation (KEMIC). This innovative, mechanical technique is free from drugs and implants, enhancing vessel compliance before traditional angioplasty procedures, making it a less invasive option compared to methods relying on implants or chemical agents.

Dr. Jordan Knepper, Chief Medical Officer at FLEX Vascular, echoed this enthusiasm, asserting that the findings establish a new paradigm in patient access interventions—highlighting improved safety, reduced need for additional procedures, and enduring results without the added complexities often seen in other methods.

Conclusion

FLEX Vascular is setting new industry standards with their commitment to innovation in the field of vascular access interventions. With the influential findings presented at the recent symposium, there's a growing optimism that the FLEX Vessel Prep System will play a pivotal role in enhancing patient outcomes, ultimately reshaping how clinicians approach vascular access treatments in the future.

About FLEX Vascular

FLEX Vascular (VentureMed Group, Inc.) is a cutting-edge, privately held medical device company from Minnesota aiming to advance endovascular technologies specifically targeting arteriovenous access and peripheral vascular operations. The company’s flagship product, the FLEX Vessel Prep™ System, is an FDA-cleared and CE Mark-approved device. Its proprietary KEMIC technology is designed to optimize vessel preparation effectively.

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Tom Michals
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Phone: +1 (763) 951-0280