Angel Catheter Combines Central Venous Catheter with IVC Filter for Pulmonary Embolism Prevention

Angel Catheter Combines Central Venous Catheter with IVC Filter for Pulmonary Embolism Prevention

SAN ANTONIO, May 15, 2012 /PRNewswire/ — BiO2 Medical, Inc. a Texas based medical device manufacturer with corporate offices in San Antonio, Texas, and R&D and manufacturing operations in Golden, Colorado, announced today that it has received CE Mark approval for the Angel™ Catheter, a Nitinol Inferior Vena Cava (IVC) filter, permanently attached to a central venous catheter (CVC) for the use of preventing Pulmonary Embolism (PE) in critically ill patients. This novel IVC filter/CVC combination device is the first IVC filter with a prophylactic use indication, and allows attending physicians the ability to place an IVC filter bedside in the Intensive Care Unit (ICU), in a procedure resembling a routine CVC placement procedure.

According to Luis F. Angel, MD, BiO2 Medical’s Chief Medical Officer and inventor of the Angel™ Catheter, “Obtaining the CE clearance for commercialization of the Angel™ Catheter in Europe is a significant step in our goal to provide an alternative for critically ill patients at high risk of Pulmonary Embolism (PE). It also validates a long and complex process of extensive testing for the use of our device as a prophylaxis against PE.”

“With CE Mark approval for the Angel™ Catheter, and preliminary safety data from a First in Man clinical study, these are exciting times for the entire team at BiO2 Medical. We’ve been working diligently over the past several years to bring this product to market, and I am justifiably impressed and proud of everyone who has helped to bring this life saving device to market,” stated Christopher E. Banas, BiO2 Medical’s Chairman and Chief Executive Officer.

The AngelTM Catheter is a truly retrievable IVC filter that is permanently attached to a multi-lumen central venous access catheter. It is intended for use in critically ill patients with VTE disease who are at increased risk of PE but for whom anticoagulation therapy is temporarily contraindicated.

The design of the Angel™ Catheter allows for easy insertion and access to the central venous system for administering medications, fluids, or blood products; blood sampling; and monitoring of central venous pressure.

The Angel™ Catheter is intended to be used during the critical time period in which anticoagulation therapy poses a high risk of complications, including major bleeding and death, and in which patients are at highest risk of VTE. The filter can be easily removed when the central line is removed, once the danger of VTE has been resolved.

The Angel™ Catheter was invented by Luis F. Angel, MD, at the University of Texas Health Science Center at San Antonio, in response to the crucial problem of PE in critically ill patients. This device takes advantage of a commonly used medical procedure, the placement of a central line, and allows for the placement of a truly temporary IVC filter as a means of PE prophylaxis in critically ill patients. These patients are at the highest risk for complications with anticoagulation therapy and are frequently too sick to be moved outside the ICU for placement of an IVC filter. Therefore, the Angel™ Catheter will allow for substantially improved PE prophylaxis and the potential for a worldwide reduction in the rates of PE-related mortality and morbidity.

BiO2 Medical has been working with Rosenbaum & Silvert, P.C., an intellectual property firm, to vigorously pursue and obtain patent protection for BiO2 Medical’s entire technology portfolio, including the designs and concepts of the Angel™ Catheter.

BiO2 Medical has received CE Mark approval for the Angel Catheter, a nitinol inferior vena cava (IVC) filter permanently attached to a central venous catheter, for the use of preventing pulmonary embolism in critically ill patients. The multi-lumen catheter can be used like a normal central venous system for administering medications, fluids or blood products, blood sampling and monitoring of central venous pressure. At the same time it provides pulmonary embolism prophylaxis by means of the attached IVC filter.

The primary patient population is critical care patients in whom anticoagulation therapy poses a high risk of complications, including major bleeding and death, and in which patients are at highest risk of venous thromboembolism (VTE). The filter can be easily removed when the central line is removed, once the danger of VTE has been resolved.

The combined central line/IVC filter makes placement easy as insertion is a bedside procedure not very different from normal central line placement and guarantees the filter is truly temporary as it slides out along with central line removal. Moreover, the design eliminates some of the potential complications of traditional IVC’s: vena cava perforation caused by hooks, filter tilting, filter migration, and irretrievability.

Source : http://www.bio2medical.com/angel-catheter/

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