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VentureMed Announces First Patient Treated With The FLEX Vessel Prep™ System AV Focused 75cm Product
By: PR Newswire Association LLC. - 05 Oct 2022Back to overview list

MINNEAPOLIS, Oct. 5, 2022 /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 today that Dr. Ari Kramer, Assistant Professor, Department of Surgery and Director, Vascular Access Program, Spartanburg Regional Healthcare System treated the first patient with the FLEX Vessel Prep System 75 cm length targeting AV access interventions including the hard-to-reach Cephalic Arch stenoses. 

"As a physician treating AV patients who rely on uninterrupted lifesaving hemodialysis, I am always looking for new technology and solutions to solve our challenging issues in AV access", said Ari Kramer, MD., "I believe Vessel Prep in AV access is essential for durability regardless of final therapy. The FLEX Vessel Prep system offers a unique non-balloon-based prep that extends patency between interventions and decreases the need for stenting. This new 75cm device is especially beneficial for me to reach and treat the very challenging cephalic arch lesions."

The first patient treated was part of VentureMed's successful Limited Market Release with the 75cm AV product in several key accounts prior to full launch. The 75cm product was created to address key voice of customer feedback that lesions in the Cephalic Arch region are often hard to reach and problematic due to complicated vasculature and complex stenoses. In addition to the longer catheter, the FLEX treatment element has been optimized to create even more consistent engagement in the vessel creating micro-incisions in the stenoses. FLEX has a unique non-balloon-based mechanism of action that creates longitudinal micro-incisions releasing circumferential tension in diseased vessels. This tension release allows FLEX to modify AV stenoses safely and effectively to improve and extend patency for all therapeutic treatments (PTA, DCB etc.), reduce complications and vessel trauma including explosive dissections that can lead to bail-out stenting, treats in-stent restenosis (ISR) and improves health-economics.

"This new 75cm AV focused product hits a sweet spot in the AV market for physicians treating AV patients even including cephalic arch lesions. Our data illustrates about 30% of AV lesions are in the cephalic arch region and our customers tell us they struggle with options for treatment." said Denis Harrington, chief executive officer and president of VentureMed. "And most importantly, our real-world data shows FLEX works. Our recent AV Registry Data shows 69% patency for Cephalic arch lesions – 211 days Freedom From Target Lesion Revascularization (FFTLR), compared with historical data of 8-52%. The FLEX AV procedure extended time between interventions for these highly compromised patients undergoing lifesaving hemodialysis therapy."

The FLEX Vessel Prep System 75cm product will be available Q4 2022. 

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. 

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SOURCE VentureMed Group

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