Boston Scientific Launches OffRoad Re-Entry Catheter System


February 5, 2014—Boston Scientific Corporation (Natick, MA) announced the United States launch and first use of the OffRoad re-entry catheter system for the treatment of chronic total occlusions in the major arteries of the legs. 

The company advised that the device received US Food and Drug Administration clearance in late 2013, after favorable results from the Re-ROUTE clinical trial. In the trial, investigators using the OffRoad system were successful in navigating challenging chronic total occlusions in 84.8% of the enrolled patients, exceeding the trial’s prespecified goals. Koen Keirse, MD, presented the Re-ROUTE data in October at the VIVA 2013: Vascular Interventional Advances conference in Las Vegas, Nevada.

According to the company, the OffRoad system is intended to help physicians navigate complete arterial blockages by traveling within the vessel’s subintimal space. Once the catheter has passed the blockage, a conical-shaped positioning balloon is used to expand the subintimal space and direct a microcatheter lancet to re-enter the vessel. This allows the interventionist to position a guidewire across the occlusion and to then treat the blockage using traditional endovascular techniques, such as angioplasty and stenting.

Boston Scientific noted that the first treatment with the OffRoad system was performed by J.A. Mustapha, MD, who is Director of Cardiac Catheterization Laboratories, Endovascular Interventions, and Cardiovascular Research at Metro Health Hospital in Wyoming, Michigan.

In the company’s press release, Dr. Mustapha commented, “In my opinion, the biggest challenge with the subintimal approach is the ability of the device to re-enter the true vessel lumen after crossing. The unique design of the OffRoad system facilitates re-entry, giving me confidence that I will be able to successfully deploy the tools I need to treat the blockage. I look forward to adding OffRoad to my endovascular toolkit to address these challenging lesions.”


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