Medical Devices: Evidence and Research (Mar 2018)
ebb® Complete Tamponade System: effective hemostasis for postpartum hemorrhage
Abstract
Ross W McQuivey,1 Jon E Block,2 Robert A Massaro3 1Clinical Innovations, Salt Lake City, UT, USA; 2Independent Clinical Consultant, San Francisco, CA, USA; 3Monmouth Medical Center, Long Branch, NJ, USA Abstract: As a leading cause of maternal death, postpartum hemorrhage (PPH) remains a worldwide obstetrical problem. However, in most cases, mortality and morbidity can be averted if efforts are immediately undertaken to achieve hemostasis. Uterine balloon tamponade has been shown to provide effective control of PPH and avoid more invasive surgical procedures and even the emergency peripartum hysterectomy. Recent clinical recommendation suggests that balloon tamponade should be considered earlier in the treatment cascade in conjunction with uterotonic agents to ensure hemostasis in the most timely fashion and maximize clinical outcomes. This paper profiles the ebb® Complete Tamponade System, a unique dual-balloon single-use device that was developed specifically for hemostatic management of PPH. The ebb system combines a uterine conforming balloon that can be rapidly deployed with a vaginal balloon that eliminates the need for vaginal packing. The description, indications for use, procedural steps, and clinical characterization of this device are presented. Keywords: postpartum hemorrhage, balloon tamponade, hemostasis, maternal bleeding