Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage

This IDE study is designed to evaluate the effectiveness and safety of the InPress Device to
treat primary PPH. The study is literature controlled.

Inclusion Criteria:

1. Adult Female, 18 years of age or older at time of consent.

2. Able to understand and provide informed consent to participate in the study.

3. Diagnosis of PPH with suspected atony within 24 hours after vaginal or c-section
delivery.

4. EBL, to be determined when investigator is ready to have InPress Device peel pack
opened: a) vaginal delivery: 500 - 1500 ml EBL or b) c-section delivery: 1000 - 1500
ml EBL.

5. Failed first-line intervention of uterotonics and uterine massage/bimanual compression
to stop bleeding. Note: Pitocin administration may continue concomitant with and post
InPress Device use.

Exclusion Criteria:

1. EBL > 1500 ml, to be determined when investigator is ready to have the InPress Device
peel pack opened.

2. Delivery at a gestational age < 34 weeks.

3. For C-sections: Cervix < 3 cm dilated before C-section.

4. PPH that the investigator determines to require more aggressive treatment, including
any of the following: a) hysterectomy, b) b-lynch suture, c) uterine artery
embolization or ligation, d) hypogastric ligation.

5. Known uterine anomaly.

6. Ongoing intrauterine pregnancy.

7. Placenta abnormality including any of the following: a) known placenta accreta, b)
retained placenta with known risk factors for placenta accreta (e.g. history of prior
uterine surgery, including prior c-section and placenta previa), c) retained placenta
without easy manual removal.

8. Known uterine rupture.

9. Unresolved uterine inversion.

10. Subject has undergone intrauterine balloon therapy or uterine packing for tamponade
treatment of this PPH prior to use of the InPress Device.

11. Current cervical cancer.

12. Current purulent infection of the vagina, cervix, uterus.

13. Diagnosis of coagulopathy.