US-based medical device manufacturer BiO2 Medical has completed clinical investigation of the Angel Catheter for pulmonary embolism (PE) protection.
As part of the trial named The Angel Catheter Clinical Trial, the company recruited 150 patients as of 2 December this year.
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The study is claimed to exceed original forecasts and concluded one year earlier than anticipated.
It commenced after receiving investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) in January this year.
The multicentre and single arm clinical investigation trial evaluated the safety and effectiveness of the catheter in subjects at high risk of PE, and with recognised contraindications to standard pharmacological therapy.
Lead primary investigator of the trial said: “We are very excited about completing this pivotal US trial. We have found that physicians are very enthusiastic about an IVC filter that can be placed at the bedside in patients at very high risk for acute DVT / PE, or those with VTE who temporarily cannot be anticoagulated.
“This novel device may not only protect patients from death from acute PE but also could dramatically reduce the number of patients who are sent home with an IVC filter. We look forward to further analysing the data.”
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 PRNewsFoto / BiO2 Medical, Inc.
