Prytime Medical Devices today said it received U.K. and CE mark approval for its ER-REBOA Plus catheter.
The Boerne, Texas-based company designed the ER-REBOA (resuscitative endovascular balloon occlusion of the aorta) catheter to improve the ease of use for controlling non-compressible truncal hemorrhage.
“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 US and Canada,” chief commercial officer Andrew Holman said in a news release. “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.”
Prytime’s catheter has an integrated arterial line for monitoring above-balloon blood pressure and an on-label guidewire-free and image-free placement with a 7 Fr sheath compatibility. ER-REBOA Plus has a pre-captured balloon and dual-sided length and zone markers with a “leave behind” guidewire capability up to 0.025 in., according to the company.
“UK and CE Mark approval for ER-REBOA Plus is another important milestone for Prytime Medical,” CEO David Spencer said. “Our mission is to deliver state-of-the-art minimally invasive solutions for hemorrhage control, so we will continue to innovate and expand access to our life-saving technology around the world.”