Medical device manufacturer BiO2 Medical has commenced the Angel Catheter Clinical Trial, with the enrollment of three patients in the study.
The company is currently involved in site initiation visits and plans to include up to 30 US sites in the multicenter, prospective and single arm clinical investigation of the Angel Catheter.
The company will be seeking a prophylactic indication for an Inferior Vena Cava (IVC) filter, at the successful completion of the trial.
Mercy Hospital in St. Louis of Missouri principal investigator Dr Ann Peick said: "So far the study has been very fluid and we’ve had wonderful access, patients and interest in participation.
"In our preliminary evaluation we’ve had very satisfactory results and no complications. At this time we have successfully inserted and retrieved two devices at Mercy Hospital."
The hospital is the first site to enroll patients for the trial.
The Angel Catheter has a retrievable Nitinol IVC filter permanently attached to a multi-lumen Central Venous Catheter, which simultaneously offers Pulmonary Embolism (PE) protection and central venous access for patients at high risk of PE.
According to the company, the Angel Catheter’s design allows for placement directly at the patient’s bedside without the need for fluoroscopy and reduces the complications of traditional IVC filters.
The Angel Catheter Clinical Trial lead principal investigator Dr Victor Tapson said: "Acute pulmonary embolism continues to be a vexing problem, particularly in high risk, ICU patients. Frequently, anticoagulant prophylaxis is contraindicated. IVC filters clearly prevent PE in the vast majority of cases."
Image: BiO2 Medical’s Angel Catheter. Photo: courtesy of PR Newswire/ BiO2 Medical, Inc.