Boston Scientific has announced the US launch and first use of the OffRoad re-entry catheter system. The system provides a new option to treat chronic total occlusions in the femoropopliteal arteries.
The first use of the OffRoad System was performed by Jihad A Mustapha, director of Cardiac Catheterization Laboratories, director of Endovascular Interventions, and director of Cardiovascular Research at Metro Health Hospital, Wyoming, USA.
The OffRoad system is intended to help physicians navigate around chronic total occlusions by travelling within the subintimal space. Once the catheter has passed the occlusion, a unique conical-shaped positioning balloon is used to expand the subintimal space and direct a microcatheter 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.
“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,” said Mustapha. “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.”
Boston Scientific received US Food and Drug Administration clearance in late 2013, following favourable results from the Re-ROUTE clinical trial.
Results from the Re-ROUTE trial, a prospective, single-arm, non-randomised, multicentre study, showed that investigators achieved an 84.8% (78/92) technical success rate using the OffRoad System to cross chronic total occlusions in the femoropopliteal arteries.
At 30 days post procedure, 75% of patients experienced an improvement of at least one category in the Rutherford classification. A 3.3% device-related major adverse event rate was seen at 30 days, which was confirmed by Boston Scientific to be below the pre-specified trial goals.