Boston Scientific has announced the US launch and first use of the OffRoad re-entry catheter system, which provides physicians with a new option for treating complete blockages in the major arteries of the leg.
The first use of the OffRoad System was performed by J A Mustapha, director of Cardiac Catheterisation Laboratories, director of Endovascular Interventions, and director of Cardiovascular Research at Metro Health Hospital in Michigan, USA.
According to a press release issued by Boston Scientific, the OffRoad re-entry catheter system is intended to help physicians navigate around complete arterial blockages by travelling within the tissue of the vessel wall (subintimal space). Once the catheter has passed the blockage, a unique 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.
“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,” says 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. In the trial, investigators using the OffRoad System were successful in navigating around challenging chronic total occlussions in 84.8% of the enrolled patients, exceeding pre-specified trial goals.