Prytime Medical Devices Receives CE Mark Approval for ER-REBOA ™ Catheter
Company looks forward to targeted market release into Europe beginning early 2017
By: Prytime Medical Devices – The REBOA Company™
"Simply put, no one should bleed to death, and the sooner you stop bleeding the better," stated David Spencer, CEO of Prytime Medical Devices. "CE Mark approval enables us to accelerate our expansion outside the U.S., while providing European clinicians an exciting new tool to temporarily stop bleeding and save lives."
The ER‐REBOA™ Catheter is the first catheter designed specifically for rapid, temporary occlusion of large vessels in the emergency and critical care environment. Key design benefits include a patented atraumatic P-TipTM, guidewire free placement, external insertion length markers, small sub 7 Fr size, and built‐in blood pressure monitoring.
"Getting our CE Mark is another major milestone for our organization,"
The company expects it will take up to 90 days to finalize its European distribution and reporting infrastructure, and plans a targeted roll out of the ER-REBOA™ Catheter to key European physicians in early 2017.
REBOA (Resuscitative Endovascular Occlusion of the Aorta) is a minimally invasive technique to temporarily occlude large vessels by using a balloon catheter. Leading trauma centers across the US are adopting REBOA as a vital temporizing adjunct to control hemorrhage, which has been identified as the number one cause of potentially survivable death in the surgical, emergency, and critical care environment.
About Prytime Medical Devices (The REBOA Company™)
Prytime medical is an innovative medical device company that designs, develops and commercializes minimally invasive solutions for trauma. The company's flagship product is the ER-REBOA™ Catheter, a patented 7 Fr compatible balloon catheter for temporary occlusion of large vessels and pressure monitoring. In addition, the company is developing multiple next generation REBOA catheters and other minimally invasive solutions of interest. More information can be found at:
Contact Number: (210) 340-0116