Postpartum hemorrhage (PPH), or excessive bleeding after childbirth. In 80% of cases, PPH is caused by uterine atony, the inability of the uterus to contract to its natural postpartum size. This leaves intra-uterine blood vessels dilated, causing severe and dangerous blood loss that can lead to maternal morbidity and death. InPress has developed an investigational, patented device to quickly stop PPH. Our device treats the cause of PPH by manually collapsing the uterus with vacuum.
At a Glance
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The InPress device applies a light vacuum to the uterine cavity to manually contract the uterus when uterine atony is identified. The device consists of an intrauterine loop, seal, and trunk. The device is inserted such that the intrauterine loop sits inside the uterine cavity and the seal is in the vaginal cavity. A vacuum cannister and regulated vacuum are then attached to the trunk of the device and a vacuum is applied. This enables the the uterus to collapse, allowing it to self tamponade and stop hemorrhage.
Do you have current users or testers?
InPress Technologies is currently conducting an FDA-approved IDE clinical study to prove safety and effectiveness of the device. This trial is expected to support regulatory submissions in the United States, Europe, and Uganda.
What Evidence do you have that your Innovation works?
In a First in Woman clinical study in Indonesia, the InPress device controlled postpartum hemorrhage within 2 minutes in all 10 cases. In each of these patients, first line treatment had failed to stop atony related hemorrhage. There was no recurrence of hemorrhage with device removal. For the ten women in this study, the InPress device:
• Prevented mortality
• Minimized blood loss and related morbidity
• Allowed for visual and tactile confirmation of treatment success
• Maintained ability to bear future children
• Required minimal trainingThis initial study was published in Obstetrics and Gynecology in July 2016.
What is your strategy for expanding use of your innovation?
InPress is currently focused on clinically testing our device and obtain regulatory clearances. With the necessary clearances in place, we plan to commercialize our device in Uganda, United States, and Europe.
We are preparing to conduct a 5-8 clinical site trial in the United States, Europe, and Uganda. This trial will support our regulatory submissions and enable commercialization in 2018.