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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.

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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The 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."

"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.