GOLDEN, Colo., Oct. 8, 2015 /PRNewswire/ -- BiO2 Medical is pleased to announce the publication of key clinical data on the use of the Angel® Catheter in Europe. This article adds to a growing body of clinical evidence on the Angel® Catheter. Additionally, enrollment for the U.S. Pivotal Study remains well ahead of schedule and continues to show promising progress.
The Angel® Catheter is a novel medical device that provides an innovative approach to Pulmonary Embolism protection. The device can be placed directly at the bedside, without the need for fluoroscopy, and ensures guaranteed retrieval once no longer indicated.
An article documenting BiO2 Medical's European registry was published in the September edition of the Journal of Trauma and Acute Care Surgery (Taccone FS, J Trauma Acute Care Surg. 2015 Sep;79(3):456-62 http://www.ncbi.nlm.nih.gov/pubmed/26307880). The article, "A new device for the prevention of pulmonary embolism in critically ill patients: Results of the European Angel® Catheter Registry," reports the results on the first 60 patients in Europe that received placement of the Angel® Catheter. The article concludes that early bedside placement of the Angel® Catheter is possible. The article suggests that this is a safe, effective alternative to short-term PE prophylaxis for high-risk patients with contraindications to anticoagulation.
The lead author of the Angel® Catheter registry article, Dr. Fabio Silvio Taccone, provided the following comment, "Critically ill patients are at risk of several life-threatening complications. Many studies have found that acute pulmonary embolism was an undiagnosed cause of death in post-mortem analyses. Unfortunately, most of these patients also have a high risk for bleeding and use of medications as thrombo-prophylaxis in this group remains limited. The use of a CVC/IVC filter, such as the Angel® Catheter, may open a new approach to preventing pulmonary embolism as it can be inserted directly at the bedside by the intensivists; it has none of the potential adverse events associated with implanted IVC filters; and it can be easily removed when the risk of bleeding is over and anticoagulants can be administered."
Additionally, the Pivotal FDA Investigation of the Angel® Catheter continues with excellent enrollment, well ahead of previous expectations. As of October 8, 2015, the study has reached 83% of the targeted evaluable subjects. This faster than expected enrollment, speaks to promising physician acceptance of the device.
For more information on The Angel® Catheter Clinical Trial, please visit clinicaltrials.gov (NCT02186223).
SOURCE BiO2 Medical, Inc.