Tokai’s Rescue Balloon Occlusion Catheter Approved in Europe

May 26, 2020—Tokai Medical Products, Inc. announced CE Mark approval for the Rescue balloon occlusion catheter, a low-profile device designed for resuscitative endovascular balloon occlusion of the aorta (REBOA).

According to Tokai, REBOA uses a balloon catheter for temporary control of noncompressible torso hemorrhage, as an alternative to traditional thoracotomy. The Rescue balloon is compatible with a 7-F sheath and 0.025-inch guidewire. Its maximum balloon diameter is 40 mm. The device also features a radiopaque tip and markerband to facilitate precise positioning under fluoroscopy.

“As REBOA [is] being used more as part of the endovascular resuscitation and trauma management (EVTM) concept worldwide, there is a great need for this excellent tool,” commented Professor Tal Hörer, MD, in Tokai’s press release. Prof. Hörer is a vascular and general surgeon from Örebro University Hospital in Örebro, Sweden. He chairs the EVTM society and is Editor-in-Chief of the Journal of Endovascular Resuscitation and Trauma Management.

Prof. Hörer continued, “The Rescue balloon has been in use for several years in Japan and other countries. It has been proven clinically to be effective, reliable, and easy to use. The Rescue balloon can be used in trauma and nontrauma cases, and as a vascular surgeon clinically active on vascular, endovascular, trauma, and resuscitation, I am looking forward to [being] able to use this product for life-saving procedures.”