ebb 2017-07-18T17:09:35+00:00

Project Description

More Than A Balloon

Postpartum Hemorrhage is consistently one of the top three causes of maternal mortality and is often the leading cause of maternal death; even in developed countries. Studies suggest that 73-93%1-2 of bleeding deaths are preventable.

Early and proper intervention is key. A rapid-response system is critical. ebb provides a complete tamponade solution to the emergency of postpartum hemorrhage.

The only dual-balloon catheter

The malleable balloon material allows the vaginal balloon to conform to the patient’s anatomy better than silicone. The uterine balloon has a fill capacity of 750 mL, and literature suggests that >500 mL may be required to achieve tamponade in 45%3 of cases. The vaginal balloon anchors the uterine balloon, reducing balloon expulsion while potentially treating vaginal bleeding if present.

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Safety First

With ebb you can monitor continued blood loss through the drain to better understand how much blood the patient has lost. Once drainage stops, check patency by flushing liquid through the irrigation port to check for concealed bleeding within the uterus.

98% Effective

“Bleeding decreased or stopped in 50/51 of the cases after balloon placement. Nearly one-half of all women required uterine balloon volumes of >500 mL to control bleeding.”

– Gary A. Dildy, MD; et al.

The maximum recommended fill volumes are 750ml for the uterine balloon and 300ml for the vaginal balloon. These volumes may be exceeded if clinically necessary.
NOTE: Fill volume ≤ 500ml is usually sufficient for tamponade.1

Initial experience with a dual-balloon catheter for the management of postpartum hemorrhage. Dildy GA, Belfort MA, Adair D, et al. Am J Obstet Gynecol. 2014;210:136.e1-6.

Use ultrasound to confirm correct placement within the uterus. When filling, keep fingertips at cervix to ensure the balloon stays in place and is not overfilled. Then a vaginal exam is recommended to ensure that the intrauterine balloon has not been overinflated, which could cause the balloon to prolapse into the vagina.
The timing of this decision is left to the clinician managing the patient. However, efforts should be made to remove or deflate the balloon within 24 hours because of the risk of infection. Ensure adequate staffing before attempting to remove the tamponade balloon in case of adverse reaction.
The catheter should be deflated until it can be atraumatically removed and the area observed for signs of persistent or recurring bleeding. Deflation of the balloon may be achieved by an incremental reduction of fluid volume followed by a period of observation until the uterine balloon is empty. If rapid fluid release is required the inflation lumen may be cut above the spike.
NEVER inflate with air. The balloons can be inflated with an IV bag, ringers lactate solution, distilled water, or any other sort of fluid typically found in the hospital.

Clinical Studies

 Senanayake

Initial experience with a dual-balloon catheter for the management of postpartum hemorrhage

Intraluminal Pressure in a Uterine Tamponade Balloon Is Curvilinearly Related to the Volume of Fluid Infused

Complete tamponade system for management of severe postpartum vaginal haemorrhage due to uterine atony

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Ordering Information

CONTACT YOUR LOCAL DISTRIBUTOR TO ORDER

ProductDescriptionQuantityPart Number
ebbebb Complete Tamponade System- Postpartum Hemorrhage Balloon1/BoxCTS-1000

1 Clark SL, Belfort MA, Dildy GA. Maternal death in the 21st century: causes, prevention, and relationship to cesarean delivery. Am J Obstet Gynecol. 2008;199:36e1-36.e5.
2 Pregnancy related mortality in the United States, 1998 to 2005. Berg CJ, Callaghan WM, Syverson C, Henderson Z. Obstet Gynecol. 2005;106:1228-12234.
3 Initial experience with a dual-balloon catheter for the management of postpartum hemorrhage. Dildy GA, Belfort MA, Adair D, et al. Am J Obstet Gynecol. 2014;210:136.e1-6.