BOERNE, Texas, Oct. 8, 2025 – Prytime Medical Devices, Inc., a leader in endovascular hemorrhage control and resuscitation, announced today the receipt of the world’s first extended duration FDA 510(k) clearance for its flagship pREBOA-PRO™ Catheter. This groundbreaking clearance allows for safe occlusion times of up to 2 hours in Zone 1, a fourfold increase compared with traditional occlusion catheters and includes an industry-defining formal definition of partial occlusion.
Science SignificanceAVB-114
The pREBOA-PRO™ Catheter represents a major scientific advance in trauma care and hemorrhage control. Unlike traditional REBOA catheters with limited 30-minute safe occlusion windows, the pREBOA-PRO™ is engineered with flow channels enabling precise, smooth manual control of blood flow. This allows surgeons to stabilize blood pressure, reduce blood loss, and mitigate distal ischemia and reperfusion injury, which are common risks with older devices. By providing extended occlusion times and controlled partial aortic occlusion, pREBOA-PRO™ enhances the ability to manage complex trauma and hemorrhagic shock cases. It allows clinicians critical additional time to stabilize patients and prepare for definitive surgical interventions, which can be lifesaving in both civilian and military settings.
Regulatory Significance
The FDA’s 510(k) clearance is a landmark regulatory milestone for Prytime. It validates the safety and efficacy of extended-duration partial occlusion in endovascular trauma management. The clearance introduces a formal definition for partial occlusion, potentially influencing regulatory standards and guidance for future hemorrhage control devices. This designation positions pREBOA-PRO™ as the first purpose-built partial occlusion catheter with FDA recognition, setting a precedent for innovation in trauma and emergency medicine.
Business Significance
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With this FDA clearance, Prytime solidifies its first-mover advantage in the global endovascular hemorrhage control market. The extended occlusion capability differentiates pREBOA-PRO™ from competitors, expanding its potential adoption in trauma centers, emergency departments, and military settings. The clearance also supports future commercial growth and investment opportunities. Prytime is positioned to scale its product footprint globally, leveraging both its innovative technology and strong clinical evidence to penetrate new markets in Europe, North America, and beyond.
Patients’ Significance
For patients experiencing life-threatening hemorrhage, pREBOA-PRO™ offers a critical survival advantage. The catheter allows surgeons to control blood flow safely for extended periods, improving stabilization during transport or preoperative care. This technology is particularly impactful for trauma, obstetric, and surgical emergencies, where rapid control of bleeding can determine outcomes. By reducing ischemic complications and enabling longer intervention windows, the device has the potential to save lives and improve clinical outcomes across diverse patient populations.
Policy Significance
The FDA approval may influence healthcare policies and trauma care guidelines. The formal definition of partial occlusion could serve as a reference point for future protocols and device standards in endovascular hemorrhage management. Additionally, the extended occlusion time supports early intervention strategies, which may shape hospital trauma protocols, emergency preparedness, and training programs globally. The clearance reinforces the importance of integrating advanced technology into life-saving care pathways.
Transaction Highlights
The FDA’s extended duration 510(k) clearance for the pREBOA-PRO™ Catheter marks a pivotal achievement in Prytime Medical Devices’ corporate trajectory. This regulatory milestone underscores the company’s leadership in endovascular hemorrhage control and its ability to translate innovation into commercially viable solutions. By enabling safe occlusion times up to two hours and introducing a formal definition for partial occlusion, the clearance significantly enhances the product’s market potential and competitive differentiation. From a business perspective, this approval positions Prytime to expand adoption across trauma centers, emergency departments, and military healthcare systems globally, strengthening investor confidence and supporting future strategic partnerships or collaborations. Overall, the milestone not only validates Prytime’s technology leadership but also reinforces its reputation as a front-runner in life-saving medical device innovation.
Source: Prytime Medical Press Release
