FDA clears Alydia's Jada system to rapidly control postpartum haemorrhage

Alydia Health announced that it received FDA 510(k) clearance of the Jada system, which is designed to provide rapid vacuum-induced bleeding control to treat postpartum haemorrhage (PPH) and abnormal postpartum uterine bleeding. CEO Rob Binney remarked that the device is a "fast, definitive and physiologic solution that enables quick and easy use before bleeding progresses too far. Speed of treatment is an essential benefit…[and] haemorrhage is visibly controlled in a matter of minutes."

According to Alydia, the Jada system treats PPH and abnormal postpartum uterine bleeding using low-level vacuum to induce the normal postpartum uterine contraction that should naturally occur after childbirth. The system consists of a thin tube with a collapsible medical-grade silicone loop that has small protected pores, which gently apply suction within the uterus.

The system "provides directly observable control of bleeding via the clear device design, continuous active suction and in-line canister to quantify blood loss," Alydia explained. The company noted that the device offers an alternative to uterotonic drugs, while other tamponade devices that rely on uterine distention to temporarily control bleeding have an average treatment time of 12 hours to 24 hours.

The FDA clearance was supported by data from the PEARLE study, which was recently published in Obstetrics & Gynecology. According to Alydia, the 106-patient study showed that the Jada system is safe and effective in using vacuum to control PPH and abnormal postpartum uterine bleeding within a median of three minutes. Specifically, the Jada system was successful in 94% of the participants, and was also rated as "easy to use" 98% of the time by the 99 investigators. The authors concluded that the system offers "a therapeutic modality that may be considered early in the treatment of abnormal postpartum uterine bleeding and postpartum haemorrhage."

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