Prytime Medical Devices Secures World’s First Extended-Duration FDA Clearance for pREBOA-PRO™ Catheter

Prytime Medical Devices, Inc. has received FDA 510(k) clearance for its pREBOA-PRO™ Catheter, marking the first clearance worldwide for extended-duration use. 

The new approval allows safe occlusion times of up to two hours in Zone 1, four times longer than previously available catheters, and establishes an industry-first formal definition for partial occlusion.

Traditionally, REBOA catheters have been used as a reactive, last-resort measure due to a 30-minute safe occlusion limit. The pREBOA-PRO™ Catheter, designed with specialised flow channels, enables precise manual control of blood flow. 

This allows surgeons to stabilise blood pressure and reduce blood loss while lowering the risk of distal ischemia and reperfusion complications associated with older REBOA devices.

The extended-duration and partial occlusion capabilities provide surgical teams with greater control during trauma cases, offering more time to intervene safely and perform definitive procedures. 

This technology represents a significant advancement in endovascular haemorrhage control, providing enhanced safety and effectiveness over traditional catheters.