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Prytime Medical Devices Achieves FDA Clearance for pREBOA-PRO™ Catheter

In a significant advancement for endovascular hemorrhage control, Prytime Medical Devices has been granted FDA 510(k) clearance for its innovative pREBOA-PRO™ catheter. This newly approved device, which greatly expands the safe occlusion time, positions Prytime at the forefront of medical technology in resuscitation and trauma care.

The pREBOA-PRO™ catheter stands apart with the capability for occlusion lasting up to two hours in Zone 1, which is four times longer than the occlusion times of existing catheters in the market. Additionally, Prytime's catheter includes an industry-first formal definition for partial occlusion, making it a versatile tool for surgeons dealing with challenging trauma situations.

Traditionally, the use of REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta) has been limited owing to its restrictive occlusion time of just 30 minutes, making it a last-resort option for many medical professionals. However, this new announcement signals a paradigm shift, offering surgeons unprecedented control in emergency situations.

“The pREBOA-PRO™ catheter is designed with the surgeon’s needs at its core, addressing a crucial limitation of traditional methods. This innovative device allows for earlier intervention, which is critical in chaotic trauma environments,” said Dr. Chance Spalding, Trauma and Critical Care Surgeon at Mount Carmel East Hospital and Chief Medical Officer at Prytime. He emphasized that achieving vascular control sooner reduces the overall pressure in medical teams, allowing them more time to formulate a thorough treatment plan.

Prytime's CEO, David Spencer, outlined the technological advancements that the pREBOA-PRO™ represents. “Surgeons have articulated their frustrations with conventional REBOA catheters, and we listened, responding by enhancing their capabilities. This is not merely about creating a balloon with fluid; it's about enabling a finely-tuned system that maximizes both surgical effectiveness and patient safety,” he stated.

The pREBOA-PRO™ is designed with advanced flow channels that permit surgeons to have precise control over blood flow, which is critical for managing blood pressure and minimizing blood loss. This new design not only enhances performance but also significantly lowers the risks associated with both distal ischemia and the complications arising from reperfusion.

The impact of this innovation extends beyond just improving medical outcomes. By providing extended occlusion times and refined control mechanisms, the pREBOA-PRO™ allows for more strategic decision-making during surgeries, which ultimately contributes to better patient survival rates.

Prytime Medical’s mission, as stated by Spencer, is clear: to offer tools that empower physicians to act decisively in emergency situations while mitigating the risks associated with trauma surgeries. The pREBOA-PRO™ catheter exemplifies this commitment, marking a pivotal moment in trauma care technology that aims to “Buy Time, Gain Control.”

As medical professionals continue to encounter increasingly complex trauma cases, solutions like the pREBOA-PRO™ catheter are vital. For further information about this revolutionary device and its applications, please visit Prytime Medical's website or reach out directly via email.

About Prytime Medical, Inc.

Prytime Medical, Inc. is a leader in the development and production of innovative medical devices aimed at improving patient outcomes in traumatic and emergency care. The company focuses on creating advanced endovascular occlusion products that enable healthcare professionals to manage severe hemorrhaging effectively, ultimately saving lives.