US-based Boston Scientific has introduced the OffRoad re-entry catheter system in the US and reported the first successful use of the device to bypass a total occlusion in peripheral leg arteries.
The OffRoad re-entry catheter system includes a balloon catheter with a micro-catheter lancet and is intended to help clinicians navigate around complete arterial blockages that might otherwise prevent minimally invasive treatment.
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The system is designed to pass around the blockage by travelling within the tissue of the vessel wall (subintimal space).
Once the catheter has passed the blockage, it re-enters the vessel lumen.
A conical-shaped positioning balloon is used to expand the subintimal space and direct the micro-catheter lancet to re-enter the lumen.
This allows the physician to position a guidewire across the occlusion and to perform angioplasties or place stents as necessary.
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By GlobalDataThe first use of the OffRoad system was performed by Dr J A Mustapha, director of Cardiac Catheterization Laboratories, Endovascular Interventions and Cardiovascular Research at Metro Health Hospital in Wyoming, Michigan.
"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," Dr Mustapha said.
Based on the fruitful results from the Re-ROUTE clinical trial, the company received the US Food and Drug Administration (FDA) clearance in late-2013.
In the Re-ROUTE trial, investigators were successful in navigating around challenging chronic total occlusions in the enrolled trial patients 84.8% of the time using the OffRoad device, exceeding the pre-specified trial goals.
Boston Scientific Peripheral Interventions president Jeff Mirviss said: "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."
According to GlobalData estimates, the US peripheral vascular devices market was valued at $2.26bn in 2012 and is expected to grow at a CAGR of 3.2% to reach $2.82bn by 2019.
Image: Boston Scientific’s Corporate Headquarters in Natick, Masschusetts. Photo: courtesy of Boston Scientific Corporation.
