Prytime Medical Announces First in European Use of New Extended Safe Occlusion Time Catheter

BOERNE, Texas, Jan. 7, 2025 /PRNewswire/ -- Prytime Medical, The REBOA Company™, proudly announces the first civilian use of its pREBOA-PRO™ catheter in the European Union, following the device's receipt of CE Mark approval. The pREBOA-PRO™ catheter is already approved in the United States and in Canada.

The pREBOA-PRO™ catheter is the world's first and only device specifically designed for prolonged aortic occlusion, a key advancement in resuscitative endovascular balloon occlusion of the aorta (REBOA). The device provides controlled resuscitation for patients with life-threatening hemorrhages, breaking the traditional 30-minute barrier associated with original REBOA¹ and offering extended safe occlusion times up to 2 hours^2,3. This breakthrough expands treatment options and may help reduce the complications typically associated with complete aortic occlusion.

Dr. Tal Hörer, Associate Professor of Surgery and Senior Vascular Surgeon at Örebro University Hospital in Sweden, performed the first European civilian use of the pREBOA-PRO™ catheter for a patient with emergent post-partum bleeding. Based on his experience, he said: "The pREBOA-PRO™ catheter represents a significant advancement in REBOA technology. Its ability to achieve partial occlusion gives us more flexibility in managing critically injured patients, potentially improving outcomes and reducing the risk of ischemic complications. This device is a valuable addition to our trauma care arsenal and allowed us to provide hemodynamic support for this critical patient."

David Spencer, CEO of Prytime Medical, commented: "Receiving CE Mark approval for the pREBOA-PRO™ catheter is a crucial step in our mission to expand access to life-saving REBOA technology globally. This innovative device will provide European physicians with a powerful tool to manage non-compressible torso hemorrhage more effectively, ultimately saving more lives."

With over 700 documented patient uses in the United States, the pREBOA-PRO™ catheter gives physicians prolonged time to evaluate, stabilize, and treat patients at risk of hemorrhagic shock, without increasing AKI^4,5,6,7,8.

Prytime Medical will begin a phased rollout of the pREBOA-PRO™ catheter across select European markets in 2025.

For more information, please visit Prytime Medical's website: www.prytimemedical.com.

About Prytime Medical Devices, Inc.
Prytime Medical Devices, Inc. is a leading innovator in resuscitative endovascular balloon occlusion of the aorta (REBOA) technology. With a mission to improve patient outcomes during trauma and critical care situations, Prytime's devices offer cutting-edge solutions designed to save lives by controlling hemorrhagic shock and preventing ischemic complications.

Dr. Horer declares no conflict of interest regarding Prytime, and has received no compensation for his opinion.

Footnotes:

1. Glaser et al., (2020) Joint Trauma System
2. Prytime Medical (2024) Data on file
3. Ho et al., (2023) J Trauma Acute Care Surg. Based on preclinical data. Clinical results in humans are unknown.
4. Russo et al., (2020) J Trauma Acute Care Surg.
5. Gomez et al., (2023) J Trauma Acute Care Surg.
6. Ronaldi et al., (2021) Shock. Based on preclinical data. Clinical results in humans are unknown.
7. Madurska et al., (2021) Eur J Trauma Emerg Surg.
8. Hunt et al., (2023) The American Surgeon

Contact:
Nicole Calvert
Marketing Manager, Prytime Medical Devices, Inc.
[email protected]
210-340-0116
www.prytimemedical.com

SOURCE Prytime Medical