#USA #Minneapolis #AV Access #VentureMed Group #FLEX Vessel Prep

Enhancing Angioplasty Outcomes with FLEX Vessel Prep™ System

At the recent Charing Cross Symposium held in London from April 23 to 25, 2025, VentureMed Group, Inc. presented compelling data regarding their innovative FLEX Vessel Prep™ (VP) System. This system aims to enhance the preparation of blood vessels in patients undergoing angioplasty, thereby increasing procedural success while reducing complications.

The first presentation at the symposium showcased the FLEX FIRST AV Registry, which analyzed six-month results from a multicenter observational registry involving 130 hemodialysis patients with arteriovenous fistulas (AVF). This group experienced access dysfunction, and the findings were promising. According to Dr. Ari Kramer from Spartanburg Medical Center in South Carolina, this system has transformed his approach to treating resistant stenoses. He emphasized that the use of controlled micro-incisions provides not only technical precision but also significant clinical effectiveness in reducing the need for re-interventions.

Key takeaways from the FLEX FIRST AV Registry include:

• - Zero serious adverse events reported during the first month of observation.
• - A remarkable 70.7% overall primary patency rate of the target lesion after six months.
• - An astonishing 76.3% patency rate for lesions located at the Cephalic Arch.
• - 100% technical success in device delivery across all procedures.

The second presentation, led by Dr. Robert Shahverdyan from Hamburg, focused on the preparation of vessels prior to drug-coated balloon (DCB) angioplasty. This approach proved to be effective in improving patency rates for hemodialysis access points. Dr. Shahverdyan reported that among patients treated with the FLEX system, the rate of re-interventions was significantly lowered compared to those treated with high-pressure, ultra-high-pressure, and scoring balloons.

Dr. Shahverdyan noted:

"After using FLEX in over 70 patients and comparing it with other techniques, the re-intervention rates are strikingly lower. The results we achieve with FLEX are not only promising but consistent across all access types, lesion locations, and patient demographics. It has become my preferred method for preparing resistant stenoses and is changing our approach toward access preservation."

The data revealed that primary patency of the target lesion (TLPP) was 86.0% at six months and 73.6% at twelve months. Additionally, re-interventions per patient year in the VP group were significantly lower (0.372) in comparison to previous methods (POBA: 0.695 and SB: 0.917, p<0.0001). Remarkably, at twelve months, 75% of patients with skull-bend interventions retained their TLPP, highlighting the efficacy of the FLEX system.

In discussing the significance of these findings, Denis Harrington, President and CEO of VentureMed Group, expressed gratitude to Dr. Kramer and Dr. Shahverdyan for their meticulous work on such important clinical studies. He stated:

"These data extend the foundation supporting the successful evidence for the FLEX Vessel Prep device. Patients requiring AV access worldwide deserve access to the technologies and algorithms demonstrated in these studies."

About VentureMed Group and the FLEX Vessel Prep™ System

VentureMed Group, Inc. is a pioneering medical technology firm focused on developing endovascular solutions for arteriovenous (AV) access and interventions addressing peripheral arterial disease (PAD). Their flagship product, the FLEX Vessel Prep™ System, is designed to optimize vascular preparation using proprietary Kinetic Endovascular Micro-incision Creation (KEMIC) technology. Unlike conventional balloon-based methods that exert static pressure, KEMIC utilizes controlled motion and dynamic vessel apposition to produce long, precise micro-incisions.

When retracted, the FLEX system applies outer pressure from the stents, ensuring continuous contact with the vessel wall, while the blade retraction generates a series of accurate micro-incisions. This unique mechanism facilitates lumen enlargement, enhances drug uptake in combination therapy, and reduces vessel trauma, consequently minimizing restenosis risk. With FDA 510(k) approval and CE mark, FLEX is setting new standards for vascular preparation and improving treatment prospects for patients globally.

For more details, visit www.VentureMedgroup.com.

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Tom Michals
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