BOERNE, Texas, - Prytime Medical Devices, Inc. has announced a new FDA 510(k) clearance for their flagship pREBOA-PRO Catheter.
The new clearance includes a dramatically expanded use profile which provides safe occlusion times up to 2 Hours in Zone 1, a four time increase from all other occlusion catheters. In addition, the new clearance contains an industry defining formal definition for partial occlusion.
REBOA has traditionally been used reactively and often as a last resort, due to extremely limited 30-minute safe occlusion times. This week's announcement highlights the evolving new capabilities now available to surgeons with the world's first and only purpose-built partial balloon occlusion technology.
The patented pREBOA-PRO Catheter is designed with flow channels which enable precise, smooth manual control of patient blood flow. PRO's ability to precisely control arterial flow enables surgeons to immediately stabilize blood pressure and reduce blood loss while simultaneously diminishing the risk of distal ischemia and detrimental reperfusion sequelae associated with old REBOA.
Dr. Chance Spalding, a Trauma and Critical Care Surgeon at Mount Carmel East Hospital in Columbus, Ohio and Prytime's Chief Medical Officer, said, "This new capability was designed with the surgeon in mind and helps eliminate a major barrier to broader utility. With this new pREBOA-PRO catheter, our surgical teams can safely intervene earlier and gain a new level of control, especially during the initial chaos seen in challenging trauma cases. Gaining control early reduces the collective temperature in the room and provides critical extended time to get to definitive intervention."
David Spencer, CEO of Prytime Medical said, "This advanced partial occlusion technology was designed to give surgeons the extended time and hemorrhage control they've been asking for. Individually and collectively, surgeons pointed out deficiencies with traditional REBOA catheters. At Prytime we listened, and we fixed them. Partial occlusion is not just letting fluid out of a balloon. By utilizing this new purpose-built partial occlusion design, physicians get a strongly enhanced risk profile while extending the window for definitive surgical repair through simple, safe flow control. pREBOA-PRO is the world's first and only catheter to give physicians the control they've been asking for."
