FLEX Vascular Announces 12-Month Real-World Outcomes Demonstrating Strong Safety, Durability, and Reduced Reinterventions with FLEX™ Vessel Prep System
LONDON, April 23, 2026 /PRNewswire/ -- Minneapolis-based FLEX Vascular announced the presentation of 12-month results from the FLEX FIRST AV Registry, a prospective, multi-center, real-world study evaluating the FLEX™ Vessel Prep System in patients with dysfunctional hemodialysis access. The data was presented at the Charing Cross (CX) Symposium in London, England on April 21, 2026, by Dr. Ari Kramer, National Principal Investigator and Chair of the Vascular Access Program at Spartanburg Regional Medical Center, South Carolina.
The study enrolled 130 patients across four U.S. centers, representing a diverse, high-risk population reflective of real-world clinical practice. The results demonstrated a compelling combination of safety, durability, and performance across complex lesion types—supporting FLEX™ Vessel Prep System as a differentiated mechanical vessel preparation strategy.
Key 12-Month Findings
- 0% serious adverse events (SAEs) at 30 days, with only a single minor complication (0.8%)
- 40% target lesion primary patency (TLPP) at 12 months in cephalic arch lesions, nearly doubling historical PTA benchmarks
- 100% secondary patency in AV grafts at 12 months, with no access abandonment
- Resulting in the elimination of 1 intervention per patient per year (on average) when FLEX is used with PTA.
"These results suggest a meaningful shift in how we approach AV access interventions," said Dr. Ari Kramer, "In a real-world population, we are seeing strong safety, fewer reinterventions, and encouraging durability—even in challenging lesions like the cephalic arch."
Real-World Evidence That Reflects Clinical Practice
The registry population included patients with significant comorbidities, including 64.6% with diabetes, 95.4% with hypertension. The patient population included 60% African American patients which reflects a broad application of the findings to everyday practice.
A New Approach to Vessel Preparation
The FLEX™ Vessel Prep System utilizes Kinetic Endovascular Micro-Incision Creation (KEMIC), a mechanical, no-drug, no-implant approach designed to optimize vessel compliance prior to standard angioplasty.
"Taken together, these findings support a new care paradigm in access intervention—one defined by improved safety, reduced reinterventions, and durable outcomes without added complexity," said Dr. Jordan Knepper, Chief Medical Officer, Flex Vascular.
About FLEX Vascular
Flex Vascular (VentureMed Group, Inc.) is a pioneering privately held medical device company based in Minnesota dedicated to advancing endovascular solutions for arteriovenous (AV) access and peripheral vascular interventions. The company's flagship technology, the FLEX Vessel Prep™ System, is an FDA 510(k)-cleared and CE Mark-approved device designed to optimize vessel preparation using its proprietary Kinetic Endovascular Micro-incision Creation (KEMIC) technology.
Media contact: Tom Michals
[email protected]
+1(763) 951-0280
SOURCE FLEX Vascular
Share this article