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The CROSSER CTO Recanalization System indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy. The CROSSER Catheter is only intended for use with the CROSSER Generator. Refer to the CROSSER Generator Manual of Operations for proper use.

The CrossER® Catheter is a high frequency mechanical recanalization system designed for recanalization of obstructed peripheral arteries. The system consists of an electronic CROSSER® Generator, Foot Switch, high frequency Transducer, and CROSSER® Catheter. The CrossER® CTO Recanalization catheter, which is intended for one procedure only, is connected to the CROSSER® Generator through the high frequency Transducer. The Foot Switch is used to activate the CROSSER® Recanalization System. The CROSSER® Generator and Transducer convert AC power into high frequency mechanical vibrations, which are propagated to the tip of the CROSSER® Catheter. The GEOALIGN® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The GEOALIGN® Markings are designated on the catheter shaft by 1cm increment bands with an accuracy within ±1mm. The distance from the distal catheter tip is labeled in 10cm increments. Thicker bands denote the midway point (5cm) between the labeled distances. The GEOALIGN® Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference regarding the location of the distal tip of the catheter or an approximate intravascular length measurement between two points. The GEOALIGN® Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GEOALIGN® Marking System.