The JADA® System

Backed by Clinical Evidence and Real-World Outcomes. Used in more than 2,000 hospitals across the U.S., join the clinicians who trust JADA® for fast, effective PPH management.

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The JADA® System is an intrauterine device indicated to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. The JADA System uses low-level vacuum to stimulate physiologic uterine contraction and control bleeding. Supported by clinical evidence demonstrating rapid bleeding control, high effectiveness, and a favorable safety profile, JADA is designed to be easy to use and help clinicians respond quickly in the management of postpartum hemorrhage.

  • Available in 2,000+ hospitals – On hemorrhage carts in more than 2,000 hospitals across the country
  • Control in 3 minutes – Bleeding Controlled (median time)
  • 98% rated JADA® easy to use – In nearly every case, investigators rated JADA easy to use1
  • 1 Minute – Uterine collapse observed (median time)2
  • 3 Minutes – Bleeding Controlled (median time)2
  • 3.2 Hours – Treatment completed and device removed (median time)2

JADA® In Focus

Rapid bleeding control, high effectiveness, and a favorable safety profile, the JADA System is designed to be easy to use and help clinicians respond quickly in the management of postpartum hemorrhage.

Vacuum-induced Hemorrhage Control

The JADA System can provide visible and observable control of bleeding within minutes.* Low-level vacuum (80 mm Hg +/- 10 mm Hg, not to exceed 90 mm Hg) induces physiologic contraction of the uterus to control and treat abnormal postpartum uterine bleeding or hemorrhage.1

In a clinical study (n=107), contraction of the uterus was observed in a median of 1 minute with control of bleeding observed in a median of 3 minutes.1

The JADA® System with Low-level Vacuum Connected

The uterus is composed of a web-like network of muscle fibers in its middle layer, called the myometrium. When the placenta separates from the uterine wall after childbirth, that portion of the myometrium is left with open blood vessels, resulting in bleeding. Typically, the uterus contracts and compression of those open vessels stops bleeding. In some instances, the uterine muscle fibers do not contract, causing uncontrolled bleeding, referred to as abnormal postpartum uterine bleeding or postpartum hemorrhage.

Uterine Contraction with the JADA® System

When connected to a low-level vacuum source (80 mm Hg +/- 10 mm Hg; not to exceed 90 mm Hg), JADA establishes a vacuum within the uterus, causing the uterus to contract and leading to control of the bleeding. In a clinical study (n=107), contraction of the uterus was observed in a median of 1 minute with control of bleeding observed in a median of 3 minutes.1

Clinical Evidence

The PEARLE study was a prospective, multicenter, pivotal, single-arm study designed to assess the safety and effectiveness of the JADA System in treating primary postpartum hemorrhage and abnormal postpartum uterine bleeding, and enrolled 107 subjects.1

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The RUBY Study was a multicenter, observational, post-market registry that collected observational data on 800 patients treated with the JADA® System from 16 US sites in the post-market setting.

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Results You Can Trust

At controlling postpartum uterine bleeding

In the PEARLE study, 94% of participants met the primary end point: bleeding was controlled successfully with JADA, and no further intervention was required. 1 (n=100/106)

Users said they would recommend JADA

Highly recommended among surveyed clinical investigators, in most cases using JADA for the first time.1 (n=104/107)

In nearly every case, investigators rated JADA easy to use

Highly recommended among surveyed clinical investigators, in most cases using JADA for the first time. 1 (n=105/107)

Safety Profile

There were no adverse events deemed definitely related to the device or the procedure, and there was a low rate of possibly device-related adverse events.

  • 5 possibly device-related adverse events were rated as “moderate,” and no event was rated as “severe.”
  • 3 moderate events were cases of endometritis, which is a known risk of long labor, vaginal exam, and postpartum hemorrhage.

JADA is made of silicone and was rated easy to use in a survey. (98%, n=105/107).1

An Intrauterine Loop has interior Vacuum Pores inside a protective Shield to evacuate blood.

An expandable Cervical Seal is filled with sterile fluid to create a seal that holds a vacuum within the uterus.

A connector at the end of the tube is attached to a regulated vacuum source.

Resources

Product Code Description Quantity
1047196 JADA System – Vacuum-Induced Hemorrhage Control (JADA-2002) 3 / box

Frequently asked questions

94% (n=100) of subjects in the PEARLE  Study had bleeding controlled in less than 10 minutes.

Leave JADA in place with vacuum applied until bleeding is controlled for 1 hour and continue to assess if the patient’s uterus is firm, bleeding is controlled, and the patient is stable. Leave JADA in place with vacuum disconnected and fluid removed from the Cervical Seal for a minimum of 30 minutes and continue to check that the bleeding remains controlled, and the uterus remains firm.

Yes. Ensure the cervix is dilated to at least 3 cm before use of JADA and verify that the hysterotomy is closed prior to insertion. JADA should be placed transvaginally; do not place through the incision.

Leave JADA in place with regulated vacuum applied until bleeding is controlled for at least 1 hour, the uterus is firm, and the patient is stable. If patient transfer is necessary, it is up to the healthcare professional’s discretion and clinical judgment.

A portable vacuum can be used as long as it is a regulated vacuum source. It can be set to “continuous” suction, and it can be set to 80 mm Hg (+/- 10 mm Hg).

There is no current restriction around using lubrication with the JADA System.

Yes, if there is no purulent infection.

The tubing that is supplied with the JADA System can hold around 100 mL of blood/fluid.

JADA is indicated for single-patient use. Reinsertion is up to the healthcare professional’s discretion and clinical judgment.

Consider prophylactic antibiotics for prolonged use.

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Backed by Clinical Evidence and Real-World Outcomes

  • Rapid Control of Abnormal Postpartum Uterine Bleeding:
94% effectiveness in controlling postpartum haemorrhage in the pivotal PEARLE study (n=100/106).1
  • High Clinician Satisfaction: 
97% of investigators would recommend JADA. 98% said JADA was easy to use, even on first‑time use.1
  • Short Treatment Duration:
Median treatment completion time: 3.2 hours, including device placement and removal.2

Indications, Contraindications, and Warnings

Indications for Use

The JADA® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.

Contraindications

  • Ongoing intrauterine pregnancy
  • Untreated uterine rupture
  • Unresolved uterine inversion
  • Current cervical cancer
  • Known uterine anomaly
  • Current purulent infection of vagina, cervix, or uterus
  • For C-sections: Cervix <3 cm dilated before use of JADA

Warnings

  • Avoid excessive force when inserting JADA into the uterus or trauma to uterine wall may occur, including perforation.
  • The safety and effectiveness of the JADA System in delivery at a gestational age <34 weeks or, if multiples, uterus judged <34 weeks size, have not been established. With smaller uterine size, there is potential for increased risk of perforation and expulsion.
  • Signs of patient deterioration or failure to improve indicate the need for reassessment and possibly more aggressive treatment and management of postpartum hemorrhage (PPH)/abnormal postpartum uterine bleeding.
  • JADA is not a substitute for surgical management and fluid resuscitation of life-threatening PPH/abnormal postpartum uterine bleeding.
  • Remove air from Cervical Seal prior to device use to minimize risk of air embolism if Cervical Seal bursts.
  • Always fill the Cervical Seal with sterile fluid. Never inflate with air, carbon dioxide, or any other gas to minimize risk of air embolism if Cervical Seal bursts.

To report an adverse event or product quality complaint for JADA, please call 844-JADAMOM.

For general inquiries or to connect with a JADA Rep: CustomerCareUSA@Laborie.com

For existing customer support: CustomerCareUSA@Laborie.com

References

1. D’Alton ME, Rood KM, Smid MC, et al. Intrauterine vacuum-induced hemorrhage-control device for rapid treatment of postpartum hemorrhage. Obstet Gynecol. 2020;136(5):882-891. doi:10.1097/AOG.0000000000004138

2. Goffman DE, Rood KM, Bianco A, et al. Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device. Obstet Gynecol. 2023;142(5):1006-1016. doi:10.1097/AOG.0000000000005366

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