Prytime Medical Announces First in Human Use of World’s First REBOA Catheter Designed to Address Ischemic Insult
BOERNE, TX, USA, April 8, 2021 /EINPresswire.com/ -- This week, Prytime Medical Devices, Inc. (Prytime) announced the worldwide first use in man of their new pREBOA-PRO™ partial Reboa catheter. Its revolutionary patent pending design is specifically engineered to enable true manual, smooth endovascular hemorrhage control. Enhanced control allows clinicians to simultaneously manage emergent truncal hemorrhage while mitigating the risk of ischemic insult and reperfusion injury. This new capability helps eliminate a major technical barrier to broader Reboa utility.
Reboa is a promising technology that provides a minimally invasive method to “internally cross-clamp” the aorta to control internal hemorrhage and provide time for definitive repair. Previous Reboa catheters provide a nearly binary “on/off” control of blood flow. The inability to smoothly transition occlusion can increase the risk of ischemic insult or reperfusion injury, especially in cases with potentially long occlusion times. The new pREBOA-PRO™ Catheter provides physicians with a first of its kind “dimmer switch” capability, allowing providers to “dial in” arterial flow past the balloon to extend safe occlusion times while also mitigating the risk of ischemic insult and re-perfusion injury.
“We are excited to be the first in the world to place this device” said Dr. Chance Spalding, Lead Trauma and Critical Care Surgeon at Grant Medical Center in Columbus, Ohio. “At Grant, we practice ‘Team’ Reboa. While first generation Reboa balloons allow for intermittent occlusion, from day one our surgeons have asked for a device to manually titrate flow to offset ischemic insult based on each individual patient’s needs. I am pleased this catheter does not require constant adjustments to maintain hemorrhage control and can simultaneously support resuscitation, freeing up our team to focus on more pressing tasks.”
“We will continue to innovate in the trauma and hemorrhage control space,” said David Spencer, CEO of Prytime Medical. “The pREBOA-PRO™ Catheter represents years of surgeon feedback and refinement. It is the first FDA cleared catheter designed specifically for true partial Reboa. The design builds on our proven ER-REBOA™ Catheter design, so it is easy to learn. Most importantly, our unique Prune Balloon™ design allows surgeons to manually use true partial Reboa for the first time.”
Although the pREBOA-PRO™ Catheter is FDA cleared, Prytime is taking a very methodical approach to its market release. They are partnering with a very select initial cohort of hospitals using a rigorous Center of Excellence approach, which emphasizes fully independent robust data collection, continual process improvement, and fanatical real-time clinical support.
About Prytime Medical Devices, Inc.
Prytime Medical™ Devices, Inc. is an innovative medical device company that designs, develops, and commercializes minimally invasive solutions for hemorrhage control. The underlying intellectual property for Reboa was conceived based on lessons learned in combat. Our latest innovation, the pREBOA-PRO™ partial Reboa Catheter, enables truncal hemorrhage control and simultaneously more controlled resuscitation in a much wider range of clinical scenarios. It is the first FDA cleared Reboa catheter designed specifically for true partial Reboa. More information can be found at www.PrytimeMedical.com
Dr Spalding reports no financial or other conflicts of interest with Prytime Medical.
Reboa is a promising technology that provides a minimally invasive method to “internally cross-clamp” the aorta to control internal hemorrhage and provide time for definitive repair. Previous Reboa catheters provide a nearly binary “on/off” control of blood flow. The inability to smoothly transition occlusion can increase the risk of ischemic insult or reperfusion injury, especially in cases with potentially long occlusion times. The new pREBOA-PRO™ Catheter provides physicians with a first of its kind “dimmer switch” capability, allowing providers to “dial in” arterial flow past the balloon to extend safe occlusion times while also mitigating the risk of ischemic insult and re-perfusion injury.
“We are excited to be the first in the world to place this device” said Dr. Chance Spalding, Lead Trauma and Critical Care Surgeon at Grant Medical Center in Columbus, Ohio. “At Grant, we practice ‘Team’ Reboa. While first generation Reboa balloons allow for intermittent occlusion, from day one our surgeons have asked for a device to manually titrate flow to offset ischemic insult based on each individual patient’s needs. I am pleased this catheter does not require constant adjustments to maintain hemorrhage control and can simultaneously support resuscitation, freeing up our team to focus on more pressing tasks.”
“We will continue to innovate in the trauma and hemorrhage control space,” said David Spencer, CEO of Prytime Medical. “The pREBOA-PRO™ Catheter represents years of surgeon feedback and refinement. It is the first FDA cleared catheter designed specifically for true partial Reboa. The design builds on our proven ER-REBOA™ Catheter design, so it is easy to learn. Most importantly, our unique Prune Balloon™ design allows surgeons to manually use true partial Reboa for the first time.”
Although the pREBOA-PRO™ Catheter is FDA cleared, Prytime is taking a very methodical approach to its market release. They are partnering with a very select initial cohort of hospitals using a rigorous Center of Excellence approach, which emphasizes fully independent robust data collection, continual process improvement, and fanatical real-time clinical support.
About Prytime Medical Devices, Inc.
Prytime Medical™ Devices, Inc. is an innovative medical device company that designs, develops, and commercializes minimally invasive solutions for hemorrhage control. The underlying intellectual property for Reboa was conceived based on lessons learned in combat. Our latest innovation, the pREBOA-PRO™ partial Reboa Catheter, enables truncal hemorrhage control and simultaneously more controlled resuscitation in a much wider range of clinical scenarios. It is the first FDA cleared Reboa catheter designed specifically for true partial Reboa. More information can be found at www.PrytimeMedical.com
Dr Spalding reports no financial or other conflicts of interest with Prytime Medical.
Julie Acosta
Prytime Medical
+1 210-340-0116
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