MINNEAPOLIS, July 30, 2024 /PRNewswire/ -- VentureMed
Group, Inc., a privately held medical device innovator in access
management for arteriovenous (AV) fistulas and grafts and vessel
preparation for interventional treatment of peripheral arterial
disease (PAD) announced it has completed enrollment of The FLEX
First AV Registry.
"I've seen firsthand how the FLEX VP system
can transform patient care." Ari
Kramer, MD, Primary Investigator
This "FLEX First" AV Registry was designed to treat subjects
with AVF/AVG stenosis to demonstrate The FLEX Vessel Prep™ System
combined with balloon angioplasty will improve the rate of target
lesion primary patency as compared with comparable published rates
of balloon angioplasty alone. This study also emphasized and
encouraged enrollment of Black/African-American and female subjects
to ensure data generation for historically underserved patient
populations and in keeping with enrollment profiles achieved in
previous VentureMed, AV Access studies. The study was a
prospective, multi-center study in 4 sites and treated 130
patients. The primary endpoint is target lesion primary patency
with patient follow-up at 6- and 12-month intervals.
"Dialysis access requires constant maintenance due to its high
natural failure rate," said Ari
Kramer, MD, Primary Investigator and Chief of AV Surgery and
Interventions at Spartanburg Regional Medical Center. "I've seen
firsthand how the FLEX system can transform patient care. By
reducing balloon pressures by one-third to one-half in many cases,
FLEX can make procedures more durable, less traumatic, and less
painful. This isn't just about technology; it's about improving the
lives of dialysis patients, helping them endure fewer interventions
and experience a better quality of life."
The FLEX Vessel Prep System has a unique non-balloon-based
mechanism of action that creates longitudinal micro-incisions that
release circumferential tension in diseased vessels. This
release of tension is how FLEX modifies AV stenoses to potentially
improve and extend patency with therapeutic treatments (PTA, DCB
etc.), and may reduce complications and vessel trauma including
severe dissections that can lead to bail-out stenting. The
FLEX Vessel Prep System is also indicated for in-stent restenosis
(ISR).
"The completion of this study comes at a very exciting time for
VentureMed as we just recently received our transitional pass
through payment (TPT) from CMS ," said Denis Harrington, president, and chief executive
officer of the VentureMed Group. "We will add this data to our
existing body of strong, published clinical evidence that
demonstrates substantial clinical improvement over the existing
standard of care (plain balloon angioplasty) and corresponding
economic value for our customers."
About VentureMed Group, Inc. and the FLEX Vessel Prep
System
The VentureMed Group, Inc. develops and markets innovative
endovascular medical devices to solve unmet medical needs in the
treatment of stenoses of AV fistulas and grafts and PAD. The FLEX
VP System is a unique, non-balloon-based approach to optimizing
revascularization by creating long controlled-depth
micro-incisions that release circumferential tension to improve
vessel compliance and enable luminal gain with less vessel trauma
that may cause restenosis. FLEX was designed to provide controlled
and predictable pre-treatment to optimize outcomes in complex
stenoses & lesions of any length or vessel morphology. The FLEX
VP System received CE Mark and 510(k) clearance from the US Food
and Drug Administration.
For more information, visit www.VentureMedgroup.com.
Media contact: Kathy Leith
Kleith@venturemedgroup.com
(763-296-2026)
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SOURCE VentureMed Group