ebb^® Complete Tamponade System: effective hemostasis for postpartum hemorrhage

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

Author contributions

All authors contributed to the conception, execution, and drafting of the manuscript and provided critical revision of the manuscript for intellectual content. All authors read and provided final approval of the version to be published. All authors agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy and integrity of any part of the work are appropriately investigated and resolved.

Disclosure

RWM is an employee of and JEB is an independent advisor to Clinical Innovations (Salt Lake City, UT, USA). The authors report no other conflicts of interest in this work.