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Innovations in Vessel Preparation: The FLEX Vessel Prep System at Charing Cross Symposium

The recent Charing Cross Symposium provided a significant platform for medical innovations, particularly focusing on the FLEX Vessel Prep™ (VP) System presented by VentureMed Group, Inc. This symposium, held from April 23-25 in London, brought together experts in vascular access and showcased real-world data that underscores the efficacy of the FLEX VP System in improving outcomes for patients undergoing treatment for arteriovenous (AV) access and peripheral arterial disease (PAD).

Understanding the FLEX Vessel Prep System

VentureMed Group is a trailblazer in medical device innovations, specifically aimed at addressing challenges related to AV access and PAD. Their flagship device, the FLEX Vessel Prep™ System, utilizes proprietary Kinetic Endovascular Micro-incision Creation (KEMIC) technology. Unlike conventional balloon methods that apply static pressure, KEMIC is designed to create precise micro-incisions in the vessel walls through controlled motion. This approach potentially enhances drug uptake in combination therapies, optimizes vessel preparation, and reduces the risk of restenosis.

Presentation Highlights from the Symposium

FLEX FIRST AV Registry Findings

Dr. Ari Kramer, the primary investigator from Spartanburg Medical Center in South Carolina, shared the results of the FLEX FIRST AV Registry, which tracked the outcomes of 130 hemodialysis patients dealing with vascular access dysfunction. The data revealed remarkable procedural safety, with zero serious adverse events noted within one month post-procedure. Specific findings included:

• - 70.7% primary patency at 6 months across all target lesions.
• - 76.3% patency rate for Cephalic Arch Lesions.
• - 100% technical success in device delivery for all procedures.

Dr. Kramer emphasized the impact of the FLEX VP System: “It’s a paradigm shift in how we think about vessel prep—transitioning from blunt force dilation to a precise, surgical-style approach.”

Comparison of Vessel Preparation Techniques

Another presentation by Dr. Robert Shahverdyan from Hamburg focused on vessel preparation preceding drug-coated angioplasty. He noted significant differences in patient outcomes when utilizing the FLEX system compared to traditional high-pressure balloon methods. Notable outcomes from the study included:

• - A primary patency rate of 86.0% at 6 months and 73.6% at 12 months for those receiving vessel prep prior to drug-coated angioplasty.
• - A marked reduction in reintervention rates per patient-year (0.372 for the VP group versus 0.695 for plain old balloon angioplasty (POBA) and 0.917 for scoring balloons).
• - In Cephalic arch interventions, 75% of the FLOW + DCB group maintained their target lesion primary patency at 12 months, contrasting starkly with no maintenance in the POBA and scoring balloon groups.

Dr. Shahverdyan noted, “The results we’re seeing with FLEX aren’t just good; they’re consistent across access types, lesion locations, and patient profiles.”

The Future of Vessel Preparation

Denis Harrington, President and CEO of VentureMed Group, praised both Dr. Kramer and Dr. Shahverdyan for their contributions, stating, “This data expands the foundation of successful evidence for the FLEX Vessel Prep system.” He underlined the importance of ensuring that AV access patients worldwide have access to the advanced technologies and methodologies demonstrated in these critical studies.

Conclusion

The FLEX Vessel Prep™ System marks a significant advancement in the field of vascular access. With an innovative approach to vessel preparation, it offers a promising alternative to traditional methods, potentially improving patient outcomes and transforming clinical practices. The ongoing research and clinical studies will further solidify its role in endovascular medicine, enhancing the quality of care for patients across the globe. For more insights and information, visit VentureMed Group.