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VentureMed Group Unveils FLEX Vessel Prep™ System Insights at Charing Cross Symposium

VentureMed Group Unveils FLEX Vessel Prep™ at Charing Cross Symposium

The Charing Cross Symposium, held from April 23 to 25, showcased groundbreaking advancements in vascular access technology, specifically featuring the FLEX Vessel Prep™ system from VentureMed Group, Inc. A leader in medical device innovations focusing on arteriovenous (AV) access and peripheral arterial disease (PAD), VentureMed's recent presentations highlighted significant findings from the FLEX FIRST AV registry and showcased real-world experiences with the system prior to angioplasty procedures.

Transforming Vascular Preparation

One of the standout presentations was led by Dr. Ari Kramer from Spartanburg Medical Center. He noted how the FLEX VP system has revolutionized his approach to dealing with resistant stenosis. According to Dr. Kramer, the controlled microincisions offered by the device not only ensure technical precision but also make a substantial clinical impact by reducing the need for reinterventions. “This is not just another tool; FLEX signifies a paradigm shift in vascular preparation, transitioning from blunt dilation to a more refined surgical approach. It's precision endovascular medicine that our patients deserve,” he stated.

The FLEX FIRST AV registry, an observational multicenter study that included 130 hemodialysis patients with AVF/ABG facing vascular access dysfunction, provided robust data on the long-term effectiveness of the FLEX VP system. Over a six-month follow-up, the results showcased the safe utilization of the system in real patient scenarios featuring complex lesion types. Notably, there were zero serious adverse events reported during the one-month follow-up period, demonstrating the system's reliability and safety profile.

Key findings from the registry revealed:

- A primary patency rate of 70.7% at the six-month mark.
- An impressive 76.3% primary patency rate for lesions in the cephalic arch.
- 100% technical success rate for device placement across all procedures conducted.

Enhancing Angioplasty Results

Dr. Robert Shahverdyan, who also presented at the symposium, shared enlightening insights from his experience with the FLEX VP in Hamburg, Germany. After using the system in over 70 patients, he concluded that the reintervention rates were markedly lower compared to traditional high-pressure balloon angioplasty and scoring balloon treatments. “The outcomes we observe with FLEX not only consistently outperform but also extend across various access types, lesion locations, and patient profiles. My preferred method for challenging stenosis has utterly shifted towards FLEX, changing our approach to access maintenance,” he explained.

The findings from Dr. Shahverdyan's research emphasized how vascular preparation prior to drug-coated balloon angioplasty significantly enhances target lesion patency rates. His results demonstrated primary patency rates of 86.0% and 73.6% at six and twelve months, respectively, when using FLEX alongside drug-coated balloons (DCBs). Furthermore, the reinterventions per patient-year in the FLEX group were considerably lower at 0.372 compared to 0.695 for plain old balloon angioplasty (POBA) and 0.917 for scoring balloon treatments (SB).

Redefining Vascular Access Technologies

Denis Harrington, President and CEO of VentureMed Group, expressed gratitude to Dr. Kramer and Dr. Shahverdyan for their relentless efforts in clinical research, emphasizing how their findings bolster the scientific foundation supporting the FLEX Vessel Prep device. “Patients worldwide with vascular access needs deserve access to proven technologies and algorithms presented in these studies,” he stated.

The FLEX Vessel Prep™ system represents a pioneering solution for vascular preparation, employing patented Kinetic Endovascular Microincision (KEMIC) technology. Unlike traditional balloon approaches, which apply static pressure, KEMIC utilizes controlled motion and dynamic vascular apposition to create precise and extensive microincisions. This innovative mechanism not only facilitates luminal gain but also enhances drug absorption when used in combination therapies, ultimately minimizing vascular trauma and decreasing the risk of restenosis.

Receiving 510(k) FDA clearance and CE marking, FLEX is poised to redefine vascular preparation practices while enhancing treatment options for patients globally. To learn more about these cutting-edge medical solutions, visit VentureMedGroup.com.