Prytime Medical Devices recently announced it has received both UK and CE mark approval for its ER-REBOA Plus catheter. Designed for improved ease of use, this catheter replaces the ER-REBOA catheter and, according to a press release, “represents an important evolution of REBOA [resuscitative endovascular balloon occlusion of the aorta] technology”.
“With this milestone, the new and improved ER-REBOA Plus catheter will now be available for patients in the UK and Europe in addition to our previous approvals in the USA and Canada,” said Andrew Holman, CCO at Prytime Medical. “REBOA interest in the global trauma community continues to grow, so we work hard to continue to bring industry best solutions to physicians worldwide. We are pleased the next-generation ER-REBOA Plus catheter is available to our expanding global community of users.”
The ER-REBOA Plus catheter maintains all the critical features of its namesake predecessor, including an integrated arterial line for monitoring above-balloon blood pressure, on-label guidewire-free and image-free placement, low-profile 7Fr sheath compatibility, and patented atraumatic P-tip to aid in positioning. Important new features of the ER-REBOA Plus include a pre-captured balloon for ease of use, dual-sided length and zone markers, and a “leave behind” guidewire capability up to 0.025″ to support transition to subsequent endovascular procedures.
“UK and CE mark approval for ER-REBOA Plus is another important milestone for Prytime Medical,” said David Spencer, CEO, Prytime Medical. “Our mission is to deliver state-of-the-art, minimally-invasive solutions for haemorrhage control, so we will continue to innovate and expand access to our life-saving technology around the world.”