San Antonio based medical device manufacturer BiO2 Medical Inc. have received U.S. Food and Drug Administration (FDA) approval of their Investigational Device Exemption (IDE) application to begin an Early Feasibility Pilot Study (EFPS) using their Angel Catheter product.
BiO2′s Angel Catheter is a truly retrievable IVC filter permanently attached to a multi-lumen central venous access catheter. Te device is intended for use in critically ill patients with Venous thromboembolism (VTE) disease who are at increased risk of Pulmonary Embolism (PE), but for whom anticoagulation therapy is temporarily contraindicated.
The primary objective of BiO2 Medical’s EFPS clinical trial is to obtain continued insight into the safety of the Angel Catheter in critically ill patients with high risk of Venous Thromboembolism disease. BiO2 Medical’s founders have been responsible for regulatory approval (FDA or CE Mark) of more than 100 medical device or diagnostic products, and have contributed to numerous successful start-up medical device companies.
The Angel Catheter’s design facilitates easy insertion and access to the central venous system for administering medications, fluids and blood products; blood sampling; and monitoring of central venous pressure, and the device is intended for use during the critical interval during which anticoagulation therapy poses high risk of complications such as 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.
Upon successful completion of the EFPS, larger pivotal trial is to follow. In the pivotal study “Angel Catheter in Critically Ill Subjects at high risk of Pulmonary Embolism Trial,” critically ill patients at increased risk for PE will receive the Angel Catheter.. critically ill patients at increased risk for PE will receive the Angel Catheter. Freedom from Pulmonary Embolism (PE) and rate of catheter-related events will be closely monitored as study endpoints.
The focus of BiO2 Medical’s planned clinical investigations is in the prophylactic patient group. The currently unmet clinical need to protect critically ill patients from the risk of Pulmonary Embolism is substantial. A number of clinical scenarios define this patient group, including but not limited to:
Subject has multiple trauma such as:
• severe head injury
• head injury with a long bone fracture
• spinal cord injury with paraplegia or quadriplegia
• multiple (≥2) long bone fractures with or without pelvic fracture
Critically ill subjects in the Intensive Care Unit with:
• hemorrhagic or ischemic stroke
• multiple organ failure
• active or recent bleeding
• severe sepsis
Critically ill subjects that have undergone or are about to undergo a surgical procedure that requires temporary (≥48 hours) interruption of medical prophylaxis. With permanent attachment of the filter to the central venous catheter, the Angel Catheter will be retrieved in all patients when the indications for IVC filtration or central venous access are no longer present. The device is intended for short-term use (less than 30 days). The Angel Catheter was the first IVC filter to receive CE Mark approval for a prophylactic indication, in addition to traditional IVC filter & CVC indications.
The Angel Catheter was invented by Luis F. Angel, MD, in response to the crucial problem of PE in critically ill patients. The Angel 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 who are at the highest risk for complications with anticoagulation therapy, and are frequently too ill to be moved outside the ICU for placement of an IVC filter. Consequently, the Angel Catheter is intended to enhance the potential for substantially improved PE prophylaxis and 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, which is the first such device to combine the functions of an Inferior Vena Cava (IVC) Filter and a multi-lumen Central Venous Catheter (CVC) for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is designed to be placed in the inferior vena cava, at the patient’s bedside, without the need for fluoroscopy, and was the first IVC Filter to receive CE Mark approval for a prophylactic indication, in addition to traditional IVC Filter & CVC indications.
BioNews Texas recently reported that the Angel Catheter is already being successfully used in the U.K. where almost 25,000 hospitalized patients die of blood clotting related disorders, and the mortality rate with Pulmonary Embolism is almost 10%.
According to BiO2 Medical’s chairman and CEO Christopher E. Banas in a release, “With this program, the FDA’s forward thinking approach will allow innovative technologies, like the Angel Catheter, to become available for patients in the U.S. in a more expeditious manner.”
The clinical investigation is being conducted as part of a new FDA program, the Early Feasibility Pilot Study Program. BiO2 Medical, Inc. is one of only nine U.S. based, medical device companies selected to participate.
The EFPS Program is structures to provide study sponsors (ie: device manufacturers), as well as FDA device reviewers, a foundation upon which to establish criteria for device modifications and/or protocol development for subsequent clinical studies. The FDA’s new approach to clinical studies is designed to facilitate development of safer, more effective products, while simultaneously expediting their availability to the patients that need them.
John A. Kaufman MD, director of the dotter interventional institute, Portland, Ore., is cited commenting: “The Early Feasibility studies are a welcome innovation that will allow physicians, industry, and the FDA to accomplish the shared goal of bringing new devices to Americans in an expeditious and safe manner. This is a great example of how close collaboration between industry and the FDA can lead to a vastly improved process and benefit our patients.”
BiO2 Medical, Inc. was founded in December 2006 by Luis F. Angel, MD, Christopher E. Banas, and Paul Castella, PhD. The company was formed to design, develop, and subsequently manufacture a range of medical products.
BiO2 Medical’s corporate headquarters is located in San Antonio, TX, and the company’s research and development (R&D) and manufacturing facility is in Golden, CO. The Golden facility is certified per ISO 13485:2003 and includes a state of the art 1,000 ft2 clean room certified as a class 8 (100,000) controlled environment (CER), which is currently dedicated to production of the Angel Catheter.
BiO2 Medical’s current primary objective is to develop and commercialize the Angel Catheter as the de facto standard of care device for the prevention of PE related mortality and morbidity in critically ill patients worldwide.
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