FlowTriever2 Catheter

The FlowTriever2 Catheter is a single-use, sterile embolectomy device designed to non-surgically remove blood clots (emboli and thrombi) from peripheral blood vessels and treat pulmonary embolism. It works via a coaxial catheter assembly with a self-expanding wireform disk that captures clots, which are then aspirated and removed through a separate delivery catheter.

The proposed device has identical fundamental design to the predicate: same vessel diameter range (6-16 mm), guidewire compatibility (0.035"), laser-cut nitinol wireform disk, delivery catheter materials (Pebax/PTFE), and dimensions. The only material modification is reduced tungsten in the tip (45% vs. 70%) and an extended shelf-life (2 years vs. 6 months). Principles of operation remain unchanged.

ISO 10993-1 (biocompatibility), ISO 11135:2014/Amd 1:2018 (sterilization by ethylene oxide), and AAMI TIR 28:2016 (sterilization standards). Sterility assurance level of 10⁻⁶ is maintained.

The submission expands indications to include pulmonary embolism treatment without changing the device's intended use, operation principle, or core technology. No significant design or material modifications were made except shelf-life and tip tungsten content, which do not affect safety or function. The FLARE-FT2 clinical study (50 patients, 7 sites) demonstrated the device met primary safety and effectiveness endpoints for PE treatment. Since the device operates identically to the predicate in the same vasculature with the same mechanism, and clinical data supports its safety in the new indication, substantial equivalence is established.