Glenveigh Medical, LLC, a Chattanooga-based firm, today announced two of its obstetrics products, the Belfort- Dildy Obstetrical Tamponade System (trade named ebb Complete Tamponade System) and the Vaginal Repair Balloon Catheter (trade named jetty Vaginal Repair Balloon) have been cleared by the FDA.
The ebb Complete Tamponade System is indicated for the treatment of postpartum hemorrhage, and the jetty Vaginal Repair Balloon is indicated for use in episiotomy repair.
Glenveigh is a specialty medical company whose product pipeline includes drugs, surgical devices, instruments, and diagnostics for obstetrics and related fields. Through an existing strategic alliance, Norgenix will be responsible for the sales and distribution of Glenveigh Medical’s devices ebb and jetty. Norgenix is licensed to sell, market, and distribute prescription drug products and medical devices in all 50 U.S. states.
Postpartum hemorrhage (PPH) is excessive bleeding of greater than 500 ml after childbirth and is the leading cause of maternal mortality worldwide. National statistics suggest that PPH occurs in up to 5% of births and is the cause of approximately 8% of maternal deaths. It is estimated that worldwide, 140,000 maternal deaths are caused by PPH per year, or 1 woman every 4 minutes. The ebb™ treats postpartum hemorrhage and helps physicians combat this serious obstetrical issue.
Marketed under the trade name ebb, the Belfort-Dildy Obstetric Tamponade System is indicated for use in temporary control or reduction of postpartum uterine bleeding. The ebb is the first rapid response balloon tamponade device that provides a complete tamponade solution for postpartum hemorrhage when time is critical. The device offers increased capacity for total conformation to the uterine cavity and, through direct rapid inflation via IV bag spike, provides quick response time. The dual balloons allow secure treatment of both uterine and vaginal bleeding, and the polyurethane material is a unique design innovation, it was stated.
“Advancing obstetrics is our goal. We provide innovative solutions in pregnancy health to improve outcomes for mothers and their babies,” stated Dr. Dave Adair, chairman and chief science officer of Glenveigh Medical. “This product addresses a critical need in obstetrics, to tackle PPH and its sometimes detrimental outcomes. We aim to increase the quality of life for both mom and baby through the products we bring to market; ebb™ is a perfect example of this.”
Additionally, Glenveigh Medical has received clearance by the FDA for its episiotomy repair device. Marketed under the trade name jetty, the Glenveigh Vaginal Repair Balloon is indicated for use during episiotomy/vaginal laceration repair to temporarily prevent the postpartum discharge of fluids from the vagina in order to assist with the episiotomy/laceration repair procedure. There are an estimated 700,000 episiotomy cases per year, and instruments used during vaginal deliveries can cause lacerations. The jetty also may solve the problem of infection caused by retained sponges that are currently used to pack the vagina and block discharge.
Rick Proctor, president and chief executive officer of Glenveigh Medical, said, “At Glenveigh, our expertise is developing innovative solutions to obstetrical challenges and bringing them to market. With the recent FDA clearance, both ebb Complete Tamponade System and jetty Vaginal Repair Balloon will directly impact patient health. We are thrilled to have the opportunity to offer a product to the market which directly addresses the challenge of PPH and may directly impact its maternal death rate.”
Michael Rackley, COO and senior vice president of Norgenix, said, “At Norgenix, it is our goal to offer quality products that provide solutions to the unmet needs within men and women’s health. We immediately recognize the immense value Glenveigh Medical’s devices may have in decreasing maternal death. With the exclusive rights to market, sell, and distribute both the ebb Complete Tamponade System and jetty Vaginal Repair Balloon in the U.S., we look forward to providing such innovations to a market with critical unmet needs.”