The OffRoad catheter is comprised of a balloon catheter with a micro-catheter lancet, designed to route past complete arterial blockages by traveling through the vessel wall. From there endovascular techniques such as angioplasty and stenting are used to treat the chronic total occlusions.
The device, which already had CE Mark approval in the European Union, won FDA clearance late last year after positive results from the Re-ROUTE clinical study, according to the release.
“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," peripheral interventions president Jeff Mirviss said in prepared remarks. "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."