VentureMed Group announced today that Ari Kramer (Spartanburg Regional Healthcare System, Spartanburg, USA) has treated the first patient with the Flex vessel prep system (75cm length), targeting arteriovenous access interventions, including “hard-to-reach” cephalic arch stenoses.
“As a physician treating AV [arteriovenous access] patients who rely on uninterrupted lifesaving haemodialysis, I am always looking for new technology and solutions to solve our challenging issues in AV access,” said Kramer. “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. This product was created to address key 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 optimised 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; reduce complications and vessel trauma, including explosive dissections that can lead to bail-out stenting; treat in-stent restenosis; and improve 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 illustrate 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, CEO and president of VentureMed. “And, most importantly, our real-world data show Flex works. Our recent AV registry data show 69% patency for cephalic arch lesions—211 days freedom from target lesion revascularisation—compared with historical data of 8–52%. The Flex AV procedure extended time between interventions for these highly compromised patients undergoing lifesaving haemodialysis therapy.”
The Flex vessel prep system 75cm product will be available in Q4 2022, according to a VentureMed press release.