Boston Scientific Launches OffRoad Re-Entry Catheter System


February 6, 2014
Boston Scientific OffRoad Re-Entry Catheter System CTO PAD Cath Labs

Boston Scientific's OffRoad Re-Entry Catheter System treats complete arterial blockages in the major arteries of the legs.  The OffRoad Re-Entry Catheter System is intended to help physicians navigate around complete arterial blockages by traveling within the subintimal space. Once the catheter has passed the blockage, a conical-shaped positioning balloon is used to expand the subintimal space and direct a micro-catheter lancet to re-enter the vessel.  This allows the physician to position a guidewire across the occlusion and to then treat the blockage using traditional endovascular techniques such as angioplasty and stenting. Boston Scientific received U.S. Food and Drug Administration (FDA) clearance in late 2013, following favorable results from the Re-ROUTE clinical trial.  For more information:

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