Medical device manufacturer BiO2 Medical has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate a clinical investigation of the Angel Catheter for Pulmonary Embolism (PE) protection.
The trial entitled ‘The Angel Catheter Clinical Trial: Prevention of Pulmonary Embolism in High Risk Subjects’ was based on positive results of a European Registry and the US Feasibility Study.
Angel Catheter study is a multicenter and single arm clinical investigation expected to enroll up to 182 subjects in around 30 US investigational sites.
Expected to begin enrolling subjects in the first quarter of 2015, the study will assess the safety and effectiveness of the catheter in subjects at high risk of PE, and with recognized contraindications to standard pharmacological therapy.
The company will be seeking a prophylactic indication, the first for an Inferior Vena Cava (IVC) Filter, at the successful completion of the study.
BiO2 Medical president and chief medical officer Dr Luis Angel said: "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."
The catheter features acute protection of a retrievable Nitinol IVC Filter permanently attached to a multi-lumen Central Venous Catheter, which simultaneously offers PE prophylaxis and central venous access for patients at high risk of PE.
Image: BiO2 Medical’s Angel Catheter. Photo: courtesy of PR Newswire/ BiO2 Medical, Inc.