BiO2 said it won an FDA nod for a pivotal trial of its Angel catheter and vena cava filter in the prevention of pulmonary embolism.
The 182-patient trial is a single-arm safety & efficacy study of the Angel device in patients at high risk for developing pulmonary embolism who can’t take standard drug therapies, according to a press release.
BiO2 said it expects to begin enrolling patients during the 1st quarter. If the trial is successful, BiO2 said it plans to seek a 1st-ever prophylactic indication for the inferior vena cava filter.
The Angel catheter is designed to provide access to the central venous system and to trap blood clots before they can reach the lungs, according to a press release. BiO2 said the Angel device is designed for bedside use without fluoroscopy and for 100% retrieval of the IVC filter, unlike other such devices.
“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," president & chief medical officer Dr. Luis Angel said in prepared remarks.
Dr. Victor Tapson of Cedars-Sinai Hospital in Los Angeles is the trial’s principal investigator, Angel said.
BiO2, which reported raising $12 million in 2012, won CE Mark approval in the European Union for the Angel catheter in May of that year.