US-based medical device manufacturer BiO2 Medical has secured investigational device exemption (IDE) approval from US Food and Drug Administration (FDA) to start 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 US feasibility study.
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The multicenter and single arm clinical investigation Angel Catheter trial is expected to enrol 182 subjects in 30 US investigational sites.
Patient enrolment is scheduled to begin in the first quarter of 2015 and the study will evaluate the safety and effectiveness of the catheter in subjects at high risk of PE, and with recognised contraindications to standard pharmacological therapy.
The company will seek a prophylactic indication, the first for an inferior vena cava (IVC) filter, at successful completion of the trial.
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BiO2 Medical president Dr Luis Angel said: "Dr Victor Tapson, a well-recognised 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."
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By GlobalDataThe 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.
