Boston Scientific Launches OffRoad Re-Entry Catheter System
System Provides Physicians New Option for Treating Complete Blockages in the Major Arteries of the Leg
Boston Scientific has announced the U.S. launch and first use of the OffRoad Re-Entry Catheter System, an important addition to the company's portfolio of tools to treat complete arterial blockages in the major arteries of the legs. These blockages, called chronic total occlusions (CTOs), are associated with advanced peripheral artery disease (PAD). The first use of the OffRoad System was performed by J.A. Mustapha, M.D., director of Cardiac Catheterization Laboratories, director of Endovascular Interventions, and director of Cardiovascular Research at Metro Health Hospital in Wyoming, Mich.
The OffRoad Re-Entry Catheter System is intended to help physicians navigate around complete arterial blockages by traveling 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," said Dr. 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 U.S. Food and Drug Administration clearance in late 2013, following favorable results from the Re-ROUTE clinical trial. In the trial, investigators using the OffRoad System were successful in navigating around challenging CTOs in 84.8 percent of the enrolled patients, exceeding pre-specified trial goals.
"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, Peripheral Interventions, 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."