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

A Breakthrough in Vascular Access: The FLEX Vessel Prep™ System

In the realm of medical innovations, the FLEX Vessel Prep™ (VP) System developed by VentureMed Group, Inc. is making substantial waves. Recently presented at the Charing Cross Symposium held in London, this cutting-edge device has shown remarkable efficacy in preparing blood vessels prior to critical procedures like angioplasty for patients suffering from arteriovenous (AV) access issues.

Enhanced Outcomes in Challenging Cases

At the symposium, Dr. Ari Kramer of Spartanburg Medical Center shared his insights from the FLEX FIRST AV Registry, highlighting compelling data from a six-month study. The findings illustrated the system's ability to optimize patient outcomes while drastically minimizing complications, marking a pivotal shift in the industry's approach toward managing resistant stenoses.

Dr. Kramer emphasized that, "The FLEX VP System has changed how I address resistant stenoses. This registry confirms my real-world experiences—the approach it takes provides both technical precision and genuine clinical benefits, specifically in reducing the need for reinterventions. This is not merely another tool; FLEX signals a transformation in our vessel prep methodology towards a more refined, surgical-style application."

In the six-month results from the registry, which studied 130 hemodialysis patients who presented with vascular access dysfunction, significant results were noted:

• - No serious adverse events reported during a one-month follow-up.
• - An impressive 70.7% overall target lesion primary patency at the six-month mark.
• - A record-high 76.3% target lesion patency observed in the challenging cephalic arch lesions.
• - A perfect technical success rate in delivering the device across all procedures.

These findings underscore the FLEX VP System's prowess in managing complex clinical situations effectively.

The Importance of Vessel Preparation

In another presentation, Dr. Robert Shahverdyan from Hamburg delved into the importance of vessel preparation before employing drug-coated balloons (DCB) for angioplasty. His extensive experience using FLEX in over 70 cases compared to other high-pressure and scoring balloons yielded consistent advantages. Dr. Shahverdyan reported lower reintervention rates with the FLEX system.

He stated, "The results we are observing are not only good—they remain consistent across varying access types, lesion locations, and patient demographics. FLEX has become my preferred method for treating resistant stenosis and is reshaping our strategies for access maintenance."

The outcomes revealed a strong favor towards the combination of vessel preparation with DCB, noting:

• - Target lesion primary patency (TLPP) rates were 86.0% at six months and 73.6% at twelve months.
• - The number of reinterventions per patient-year was considerably lower in the vessel prep group than in the group using plain old balloon angioplasty (POBA) and scoring balloons.
• - Particularly in cephalic arch lesions, 75% maintained TLPP at one year, showcasing FLEX's unique capabilities in this challenging area.

A Bright Future for AV Access Patients

Denis Harrington, President and CEO of VentureMed Group, expressed gratitude towards Dr. Kramer and Dr. Shahverdyan for their rigorous efforts in executing these clinical studies. He stated, "This data strengthens the foundation for the FLEX Vessel Prep device's success. Patients requiring AV access around the globe should not only expect solutions—they deserve access to the innovations displayed in these studies."

VentureMed’s FLEX Vessel Prep System stands as a beacon of hope for millions battling vascular access issues, changing traditional paradigms in medicine with its proprietary Kinetic Endovascular Micro-incision Creation (KEMIC) technology. Unlike conventional static pressure methods, KEMIC’s dynamic approach facilitates minute incisions while minimizing vessel trauma, potentially reducing the risk of restenosis.

With FDA clearance and CE Mark approval, the FLEX system is paving the way for enhanced treatment options for patients worldwide. For those looking to delve deeper into this groundbreaking innovation or to explore further clinical studies, VentureMed Group provides a wealth of information on its website at VentureMedgroup.com.