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The ROVO Mechanical Thrombectomy Device is indicated for the removal and thrombi from vessels in the peripheral vasculature.

The ROVO Mechanical Thrombectomy Device is indicated for the removal of soft emboli and thrombi from vessels in the peripheral vasculature. It consists of a ROVO Driver, a ROVO Locking Aspiration Syringe, and a ROVO Catheter. The ROVO Driver handpiece was designed to work with an off-the-shelf catheter manufactured by Merit Medical Systems, Inc (K121051 and K132409) and an off-the-shelf locking aspiration syringe (K163597) also manufactured by Merit Medical Systems, Inc. Both the catheter and syringe are private labeled with the ROVO system name. The ROVO Catheter is maneuvered under fluoroscopic observation to the location of the target thromboemboli utilizing the surgeon's preferred vascular access procedure. Once in the desired location, the ROVO Driver handpiece with the ROVO Locking Syringe is attached to the catheter. Squeezing of the handpiece rotates the distal tip of the ROVO Driver. This rotation ensures the thromboemboli is loosened and the catheter tip is fully exposed to the vessel to completely capture and aspirate the thromboemboli. Rotation does not happen when the trigger is released. Aspiration of the emboli/thrombi happens upon release of the Locking Syringe, independent of the catheter rotation. During aspiration, the surgeon can continue to pull the trigger and move the catheter as needed to capture the target thromboemboli.