FDA clears device for postpartum bleeding

The FDA recently granted 510(k) clearance for Jada System, a device its manufacturer said “rapidly controls and treats postpartum hemorrhage and abnormal postpartum uterine bleeding.”

Postpartum hemorrhage is the leading cause of maternal mortality worldwide, according to Dena Goffman, MD, chair of the obstetrics and gynecology department at Sloane Hospital for Women at NewYork-Presbyterian and Columbia University’s Irving Medical Center, and colleagues. The researchers evaluated the safety and effectiveness of Jada System (Alydia Health) in a multicenter, prospective, single-arm treatment trial that was recently published in Obstetrics & Gynecology.

Goffman told Healio Primary Care that the device can be used by women who cannot benefit from other postpartum hemorrhage and abnormal postpartum uterine bleeding treatments.

“Some patients are not able to be treated with certain uterotonics due to medical contraindications,” she said. “Jada is a safe and effective option for women with postpartum bleeding that works quickly and has a short overall treatment time, which allows patients to resume postpartum activities.”

Alydia Health said the device consists of a thin tube with a collapsible, silicone loop that is placed in the uterus. The tube then applies suction to the uterus to control bleeding.

According to the company, the FDA’s clearance of the device was based on its performance in the PEARLE trial. Goffman and other PEARLE investigators wrote that 94% (95% CI, 88%–98%) of 106 women with primary postpartum hemorrhage or abnormal postpartum uterine bleeding were successfully treated with the Jada System within a median of 3 minutes (interquartile range = 2–5). The mean age of the women in the study was 29.7 years, 57% of them were white and 24% were Black.

PEARLE investigators also wrote that adverse events tied to Jada System’s use included four cases of endometritis and one occurrence each of bacterial vaginosis, vaginal candidiasis, presumed endometritis and vaginal laceration repair disruption. These events were “resolved with treatment and without serious clinical sequelae,” the researchers wrote. They added that among the 99 physicians who participated in PEARLE, 98% described the device as “easy to use” and 97% said they would recommend it.

Rob Binney, CEO of Alydia Health, told Healio Primary Care the device’s price was still being negotiated with hospitals at the time of this story’s posting.

Reference:

• Press Release