IDE Approved for Pivotal Trial of BiO2 Medical's Angel Catheter

January 8, 2015—BiO2 Medical announced approval of an investigational device exemption (IDE) from the US food and Drug Administration to initiate a clinical investigation of the company’s Angel catheter for pulmonary embolism (PE) protection in high-risk patients. Victor Tapson, MD, is Principal Investigator for the trial, which will build on the positive results of a European Registry and a United States feasibility study. Patient enrollment is expected to begin in the first quarter of 2015.

According to BiO2 Medical, the upcoming trial is a multicenter, prospective, single-arm clinical investigation that is expected to enroll up to 182 patients at up to 30 investigational sites in the United States. The primary objective of the study is to evaluate the safety and effectiveness of the Angel catheter in patients who are at high risk for PE and have recognized contraindications to standard pharmacological therapy. At successful completion of the study, BiO2 Medical will be seeking a prophylactic indication for this inferior vena cava (IVC) filter.

According to the company, the Angel catheter features the rapid and acute protection of a retrievable nitinol IVC filter that is permanently attached to a multilumen central venous catheter. The device simultaneously provides PE prophylaxis and central venous access for patients at high risk for PE. 

Designed to allow for placement directly at the patient’s bedside without the need for fluoroscopy, the device significantly reduces the complications of traditional IVC filters by ensuring 100% removal of the IVC filter when the catheter is retrieved. The expected prophylactic and temporary capabilities of the device will provide a new treatment option for a wide range of underserved patients, including trauma, critical care, and neuro patients, stated BiO2 Medical.