Press Release (ePRNews.com) - BOERNE, Texas - Jun 20, 2017 - Prytime Medical Devices, Inc. today announced that the first patient has been enrolled in the company’s Emergent Truncal Hemorrhage Control Study.
The purpose of the study is to collect detailed prospective information on current use of the Prytime ER-REBOA™ Catheter and other emergent hemorrhage control interventions (thoracotomy, laparotomy and interventional radiology) for treatment of non-compressible truncal hemorrhage arising below the diaphragm. Significant detailed hemorrhage control and complication information will be collected which may allow analysis and optimization of best practices.
The study is designed as a real-world, prospective observational study of current standard of care at six U.S. Level 1 Trauma Centers including the University of Texas Health Science Center at Houston (UTHealth), Maryland Shock Trauma, Denver Health, Los Angeles County, University of Washington (Harborview) and Emory university/Grady Memorial Hospital. The study will enroll up to 500 patients over the next 18 months.
“Starting enrollment in this multicenter observational study is important, as we need high quality data to help guide optimal use of this exciting technology.” Stated Dr. John Holcomb, CMO of Prytime Medical.
“We’re honored to be able to work with world renowned researchers and trauma centers to collect meaningful real-world data on use of our catheter and other emergent hemorrhage control interventions.” Stated David Spencer, President and CEO of Prytime Medical. “Data management and study coordination will be led by the Center for Translational Injury Research at UTHealth, Houston TX. Their involvement and leadership will ensure integrity and independence of the study.”
This clinical study is supported by the U.S. Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division, under Contract No. W911QY-15-C-0099.
REBOA (Resuscitative Endovascular Occlusion of the Aorta) is a FDA cleared minimally invasive technique to temporarily occlude large vessels by using a balloon catheter. More than 84 leading trauma centers across the US are using REBOA as a vital temporizing adjunct to control hemorrhage, which has been identified as the number one cause of potentially survivable death in the surgical, emergency, and critical care environment.
About Prytime Medical Devices (The REBOA Company™)
Prytime Medical is an innovative medical device company that designs, develops and commercializes minimally invasive solutions for trauma. The company’s flagship product is the ER-REBOA™ Catheter, a patented 7 Fr compatible balloon catheter for temporary occlusion of large vessels and pressure monitoring including patients requiring emergency control of hemorrhage. The company is developing multiple next generation REBOA catheters and other minimally invasive solutions of interest. More information can be found at www.prytimemedical.com or by calling (210) 340-0116.