INFORMATIVE       

Clinical Innovations Receives CE Mark for its Kiwi^® Omni-C™ Vacuum-Assisted Delivery Device for C-Sections

Salt Lake City, UT, March 14, 2007 – Clinical Innovations, LLC, a division of ACI Medical Devices, Inc., announced today that it has received the CE Mark for a new vacuum-assisted delivery device for Cesarean section deliveries. Designed specifically for use in the confined space of the abdominal cavity, the Kiwi Omni-C is clinically proven to promote fewer hysterotomy extensions, to reduce blood loss, and to decrease cervical lacerations.

The Kiwi Omni-C vacuum cup has a low profile and a flexible stem for easy insertion and maneuverability. This facilitates proper placement of the cup on the flexion point, located 3 cm forward of the posterior fontanelle along the sagittal suture, and enables the smallest diameters of the fetal head to be delivered. The Omni-C also has finger grooves for improved cup grip, and a baffle filter for adequate vacuum dispersion.

The development of the Kiwi Omni-C is in direct response to the increasing rates of c-section deliveries, which hit an all time high of 29.1% in 2004 (National Center for Health Statistics). With the rise in c-sections, clinicians are increasingly concerned that the increase in these procedures may lead to increased risks to mother and baby.

“The Kiwi Omni-C was developed to assist in safe and effective c-section deliveries, in light of an increased procedure rate,” said Wm. Dean Wallace, MD, PhD, and Sr. Vice President of Research & Development for ACI Medical Devices. “The low profile and flexibility of the cup help minimize the incision size and decrease morbidity associated with a surgical procedure like a c-section.”

Indeed, the Kiwi Omni-C is clinically proven to help reduce blood loss, hysterotomy extensions and cervical lacerations (R.W. McQuivey, V. LaPorte and A. Vacca. Vacuum-Assisted Delivery of the Fetal Head at Cesarean Section. 1st Beijing International Conference on Obstetrics and Gynecology, 7-10 October 2005). It also provides easy access to the high floating head during repeat c-sections, assistance for failed vaginal deliveries when the fetal head has descended low into the birth canal, and reduced pressure on the uterus.

About Clinical Innovations

Clinical Innovations develops, manufactures and markets state-of-the-art medical devices that improve healthcare outcomes for clinicians and their patients worldwide. With particular emphasis on healthcare solutions for women and their infants, Clinical Innovations employs high quality standards in every aspect of business to make advancements in technology and bring innovative ideas to life.

Since its inception in 1993, Clinical Innovations has consistently expanded its worldwide presence, becoming the market leader in several product categories, including the Koala^® Intrauterine Pressure System and the Kiwi^® Vacuum-Assisted Delivery System. With ISO13485 certification and strong relationships with top worldwide medical distributors, Clinical Innovations has the systems and infrastructure in place to promptly respond to market trends and customer suggestions.

More information can be found at Clinical Innovations’ web site www.clinicalinnovations.com or by calling 801-268-8200.