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The Food and Drug Administration has cleared updates to the Jada® System, a medical device intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.
The Jada System is comprised of an intrauterine device that utilizes low level vacuum to induce normal contraction of the uterus, thereby providing control of abnormal uterine bleeding.
Jada was first approved in August 2020 based on data from the PEARLE IDE study (ClinicalTrials.gov Identifier: NCT02883673), which showed that the device was 94.3% effective (n=100/106; P <.001) at controlling postpartum hemorrhage (primary end point; defined as the avoidance of nonsurgical, second-line or surgical intervention to control uterine hemorrhage after the use of the Jada System).
The latest approval provides for a new kit configuration with updated packaging, as well as design changes to improve ease of use. The updated Jada System is expected to be available in January 2022.
References
- Organon receives FDA clearance for technological updates to the Jada® System, a medical device intended to control postpartum hemorrhage. News release. Accessed October 11, 2021. https://www.businesswire.com/news/home/20211011005040/en/Organon-Receives-FDA-Clearance-for-Technological-Updates-to-the-Jada%C2%AE-System-a-Medical-Device-Intended-to-Control-Postpartum-Hemorrhage.
- Jada System [instructions for use]. Organon; 2021. Accessed October 12, 2021.
