Remember BiO2 Medical and its Angel® Catheter for Pulmonary Embolism (PE) protection, CE marked in 2013 and at the time starting a pilot study, as we reported here. Now the company has gained the U.S. FDA’s approval to commence an IDE clinical investigation to pave its way to market in the United States.
The Angel® Catheter features the rapid and acute protection of a retrievable Nitinol IVC Filter, permanently attached to a multi-lumen Central Venous Catheter, which simultaneously provides PE prophylaxis and central venous access for patients at high risk of PE. The novel design of the Angel® Catheter allows for placement directly at the patient’s bedside without the need for fluoroscopy and significantly reduces the complications of traditional IVC filters by ensuring 100% removal of the IVC filter when the catheter is retrieved.
The IDE study, entitled The Angel® Catheter Clinical Trial: Prevention of Pulmonary Embolism in High Risk Subjects, will build on the positive results of a European Registry and a U.S. Feasibility Study and is expected to begin to start enrolling subjects this quarter. It is a multicenter, prospective, single arm clinical investigation of up to 182 subjects in up to 30 U.S. investigational sites. The primary objective is to evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE, and with recognized contraindications to standard pharmacological therapy. At the successful completion of the study, BiO2 Medical will be seeking a prophylactic indication, which would be the first for an Inferior Vena Cava (IVC) Filter.
“The Pivotal Clinical Trial is the culmination of years of investigation in this clinical device. The results of this trial will also provide the important clinical data to understand the prophylactic role of this IVC filter and catheter combination. Dr. Victor Tapson, a well-recognized expert in the area of Pulmonary Embolism is the Principal Investigator for this trial, in association with a large group of trauma and critical care physicians who feel that positive results of this trial will provide a substantial contribution in the prevention of significant Pulmonary Embolism events that are associated with increased morbidity and mortality,” stated Dr. Luis Angel, BiO2Medical’s President & Chief Medical Officer.
Source: BiO2 Medical, Inc.