BiO2 Medical Gets FDA Nod to Start IDE Trial of Its Angel Catheter

San Antonio, Texas-based devicemaker BiO2 Medical has secured FDA approval to begin a clinical trial of its Angel catheter for pulmonary embolism protection. The trial will enroll up to 182 patients at 30 U.S. sites beginning this quarter, the devicemaker said.

The single-arm study will gauge the safety and efficacy of the Angel Catheter in subjects at high risk of PE, building on positive results gleaned from a European registry and a U.S. feasibility study, BiO2 said. Once completed, BiO2 will seek a prophylactic indication, the first for an inferior vena cava filter.

The catheter offers the acute protection of a retrievable Nitinol IVC filter, permanently attached to a multilumen central venous catheter and can be placed directly at the patient’s bedside without fluoroscopy, according to BiO2. Complete removal of the filter is ensured when the catheter is retrieved — significantly reducing complications that can occur with traditional IVC filters, the company added.

BiO2 President Luis Angel said the device has been well-received by trauma and critical care physicians. — Kellen Owings