ER-REBOA PLUS™ Catheter Earns UK and CE Mark Approval

USA - Deutsch

USA - español

USA - Français

News provided by

May 24, 2021, 13:27 ET

BOERNE, Texas, May 24, 2021 /PRNewswire/ -- Prytime Medical Devices, Inc. announced today it has received both UK and CE Mark Approval for its next-generation ER-REBOA PLUS™ Catheter. Designed for improved ease of use, this catheter replaces the market defining ER-REBOA™ catheter and represents an important evolution of REBOA technology. The new catheter is REBOA Refined 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," 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 world-wide. 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 the only integrated arterial line for monitoring above-balloon blood pressure available on the market, industry leading 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 hemorrhage control, so we will continue to innovate and expand access to our life-saving technology around the world."

To learn more about Prytime Medical™ and the ER-REBOA PLUS™ Catheter, visit www.prytimemedical.com, email [email protected] or call +1 (210) 340-0116.

About Prytime Medical Devices, Inc.
Prytime Medical™ Devices, Inc. is an innovative medical device company that designs, develops, and commercializes minimally invasive solutions for hemorrhage control. In trauma, hemorrhage is the leading cause of potentially survivable death. Non-compressible truncal hemorrhage is of particular interest, because of the limited clinical options available to stop bleeding prior to surgery. The underlying intellectual property for the original ER-REBOA™ technology was conceived by experienced military vascular surgeons, based on lessons learned in war. The new ER-REBOA™ PLUS Catheter represents an important evolution of REBOA and includes several new convenience features based on experience and input from civilian trauma surgeons from around the world.