BiO2 Medical said today the pivotal clinical trial of its Angel catheter hit its target of 150 evaluable patients and has concluded a solid year earlier than anticipated.
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 the San Antonio, Texas-based company.
“We are very excited about completing this pivotal U.S. 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 analyzing the data,” lead primary investigator Dr. Victor Tapson said in a press release.
The company said it is preparing for an anticipated launch of the Angel catheter following FDA 510(k) approval some time between the 2nd and 3rd quarter of 2016, 18 months ahead of schedule.
In January, BiO2 won a nod from the FDA for a 182-patient pivotal trial of the device in patients at high risk for developing pulmonary embolism who can’t take standard drug therapies.
In May, BiO2 said it enrolled 40 patients within the first 3 months of the trial starting, with 13 sites actively enrolling subjects for the single-arm investigation.
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.