Re-ROUTE Data Presented for Boston Scientific's OffRoad Re-Entry Catheter System

October 8, 2013—Boston Scientific Corporation (Natick, MA) announced that the company's OffRoad re-entry catheter system demonstrated excellent performance in facilitating the treatment of chronic total occlusions (CTOs) in the major arteries that supply blood to the legs. The data from the Re-ROUTE clinical trial were presented by Koen Keirse, MD, during a late-breaking clinical trial session at the VIVA 2013: Vascular Interventional Advances conference in Las Vegas, Nevada. Dr. Keirse is from the Regional Hospital Heilig Hart Tienen in Tienen, Belgium.

According to Boston Scientific, the Re-ROUTE trial is a prospective, single-arm, nonrandomized, multicenter postmarket study conducted in Europe and Canada. The Re-ROUTE trial investigators achieved an 84.8% (78/92) technical success rate using the OffRoad system to cross CTOs in the femoropopliteal arteries. At 30 days postprocedure, 75% of patients experienced an improvement of at least one category in the Rutherford classification. A 3.3% device-related major adverse event rate was seen at 30 days, which is below the prespecified trial goals.

Andrej Schmidt, MD, is principal investigator of the Re-ROUTE trial. In the company's press release, Dr. Schmidt commented, “CTOs in the legs can lead to pain due to lack of blood flow. They also are an indicator of increased risk for major cardiovascular events and can lead to limb amputation and an overall diminished quality of life. In my experience, I found the OffRoad system to be a very effective tool for navigating around these challenging blockages, enabling me to treat more patients with peripheral artery disease." Dr. Schmidt is from Parkhospital Leipzig, Center for Vascular Medicine in Leipzig, Germany.

Boston Scientific stated that the OffRoad re-entry catheter system includes a balloon catheter with a microcatheter lancet and is intended to help physicians navigate around complete arterial blockages that might otherwise prevent minimally invasive treatment. The system is designed to pass around the blockage by traveling within the tissue of the vessel wall—the subintimal space. Once the catheter has passed the blockage, it re-enters the vessel lumen. The device's conical-shaped positioning balloon is used to expand the subintimal space and direct the microcatheter lancet to re-enter the lumen, allowing the physician to position a guidewire across the occlusion and treat the blockage using traditional endovascular techniques such as angioplasty and stenting.

The OffRoad re-entry catheter system has received European CE Mark approval. In the United States, US Food and Drug Administration 510(k) clearance is pending and it is currently not available for sale. Data from the Re-ROUTE trial are supporting the regulatory submissions in the United States, advised Boston Scientific.