Safety and Effectiveness of the JADA® System

Clinical evidEnce

The Evidence Is In

The JADA^® System was evaluated in two US clinical trials: the PEARLE study and the RUBY study.

The PEARLE Study

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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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)

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Bleeding Was Controlled Within 3 Minutes

Uterine Collapse

1 min.

(median time)
Uterine Collapse Observed

Bleeding Controlled

3 min.

(median time)
Bleeding Controlled

Treatment Completed

3.2 hrs.

(median time)
Treatment completed and device removed

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.

The Ruby Study

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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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: jadainfo@organon.com

For existing customer support: USDirectCS@organon.com

Reference

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