Crux Biomedical, Inc. is sponsoring several clinical research studies to evaluate the safety, efficacy and performance of its vena cave filter system. The device is considered investigational and can only be used in appropriately regulated clinical studies.
A first-in-man study was completed by Dr. Adrian Ebner starting in December 2006. Dr. Ebner practices at the Hospital Privado Frances in Asuncion, Paraguay and at the Canadian med center, in Rochester, United States. Ten patients were enrolled. The Crux Vena Cave Filter system was successfully used in all ten patients.
Currently, Crux is sponsoring three clinical studies. One study is an FDA Approved IDE (Investigational Device Exemption) study enrolling in the U.S. The second and third studies are in Belgium and Australia/New Zealand, respectively. The studies are being conducted to support regulatory submission in numerous regions worldwide.
Each of the ongoing studies are single arm, multicenter protocols designed to evaluate the Crux Vena Cava Filter System in patients at risk for a pulmonary embolism due to contraindicated or failed anticoagulation medications.
For additional information: www.ClinicalTrials.gov