InPress Technologies’ postpartum hemorrhage control device has successfully completed its first clinical trial at three Indonesian hospitals, the Mountain View, Calif., devicemaker announced Wednesday.
Within two minutes of InPress device placement, hemorrhage control took effect and full control occurred at an average of just over two hours. These findings from a 10-patient study in 2014 are significant because most PPH devices require 10 to 24 hours to attain full hemorrhage control, the company claims.
The InPress device, meant to be inserted into the uterus upon childbirth, was developed to counteract uterine contraction problems, the most common underlying cause of PPH. The product works by producing an immediate, vacuum-induced tamponade effect that returns postpartum uterine contractions to normal and could reduce maternal mortality and healthcare costs, the devicemaker says.
The InPress device is novel in that it quickly promotes the body’s natural response and has the potential to systemically alter how PPH is treated worldwide, says Dr. Sabaratnam Arulkumaran, Professor Emeritus of Obstetrics and Gynecology at St. George’s, University of London.
PPH is the leading cause of perinatal maternal death worldwide. Pending FDA approval, InPress plans an investigational clinical trial for late this year. — Jason Scott