Boston Scientific on Wednesday announced the U.S. launch and first use of its OffRoad Re-Entry Catheter System, used to treat complete arterial blockages in the major arteries of the legs. Called chronic total occlusions (CTO), such blockages are associated with advanced peripheral artery disease.

The first use of the OffRoad System was performed at a hospital in Wyoming, Mich.

The OffRoad system helps doctors navigate around complete arterial blockages by traveling outside the main channel of the artery but within the tissue of the blood vessel wall (subintimal space). Once the catheter has passed the blockage, a conical-shaped positioning balloon expands the subintimal space and directs a tiny lancet to re-enter the vessel. The doctor can then position a guidewire across the blockage and treat it using traditional 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 Dr. J.A. Mustapha, director of Cardiac Catheterization Laboratories, director of Endovascular Interventions and director of Cardiovascular Research at Metro Health Hospital in Wyoming, Mich. “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 U.S. Food and Drug Administration clearance in late 2013, after a favorable clinical trial. Investigators using the OffRoad System were successful in navigating around challenging blockages in 85 percent of the enrolled patients, exceeding trial goals, Boston Scientific said.

"CTOs represent one of the most challenging forms of peripheral artery disease, putting patients at great risk of limb amputation and major cardiovascular events such as heart attack and stroke,” said Jeff Mirviss, president of Peripheral Interventions at Boston Scientific. “Physicians rely on a variety of technologies and techniques to treat this condition, and with the addition of the OffRoad Re-Entry catheter system, we believe Boston Scientific is well-positioned to meet those needs with a complete portfolio of CTO solutions.”