BiO2 Medical's Angel Catheter to Be Studied Under FDA's Early Feasibility Pilot Program

May 1, 2013—BiO2 Medical, Inc. (San Antonio, TX) has announced that the US Food and Drug Administration (FDA) approved the company's investigational device exemption application to begin an Early Feasibility Pilot Study (EFPS) using the BiO2 Angel catheter. The primary objective of the company's clinical trial is to obtain continued insight into the safety of the Angel catheter in critically ill patients who are at high risk for venous thromboembolism disease.

According to the company's press release, the Angel catheter combines the functions of an inferior vena cava filter and a multilumen central venous catheter for the prevention of pulmonary embolism and to access the central venous system. The device is designed for placement in the inferior vena cava, at the patient's bedside, without the need for fluoroscopy. The Angel catheter received CE Mark approval for a prophylactic indication in addition to the traditional inferior vena cava filter and central venous catheter indications, advised the company.

The clinical investigation is being conducted as part of a new FDA EFPS program that provides study sponsors/manufacturers and the agency's device reviewers with a foundation to establish criteria for device modifications and/or protocol development for subsequent clinical studies. The company stated that the FDA's new approach to clinical studies seeks to facilitate the development of safer, more effective products while expediting their availability to the patients who need them. BiO2 Medical is one of nine United States medical device companies selected to participate in the EFPS program.

In the BiO2 press release, John A. Kaufman, MD, who is Director of the Dotter Interventional Institute in Portland, Oregon, commented, “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.”