Boston Scientific Launches TruePath CTO Crossing Device

February 8, 2012—Boston Scientific Corporation (Natick, MA) announced the launch of the TruePath chronic total occlusion (CTO) device in the United States. The TruePath device is designed to facilitate the crossing of CTOs in the peripheral vasculature.

The company will begin marketing the product immediately in the United States and expects to launch the product in Europe and other international markets in the first half of 2012. Boston Scientific acquired the TruePath technology through its acquisition of ReVascular Therapeutics, Inc. (Sunnyvale, CA) in February 2011. The TruePath CTO device has received US Food and Drug Administration 510(k) clearance and CE Mark approval.

According to Boston Scientific, the TruePath CTO device features a rotating diamond-coated tip that is designed to break through occluded peripheral arteries and facilitate the placement of conventional guidewires for treatment of peripheral lesions. The device is designed with an ultra-low 0.018-inch profile for optimal crossing. Once positioned, the distal tip rotates at 13,000 rpm to facilitate drilling through calcified lesions and other fibrous blockages. The company advised that the TruePath device requires no capital equipment and is available with an optional extension wire to facilitate catheter exchange and increase the working length beyond 300 cm.

The TruePath device was evaluated in the ReOpen clinical study, which was composed of 85 patients with peripheral artery lesions. Study results demonstrated that the device is safe and effective in facilitating the crossing of intraluminal CTOs after resistance or previous failed attempts with a conventional guidewire. In the study, technical success (defined as facilitation of CTO crossing) was achieved in 80% of patients, and improved postprocedure blood flow was observed in 82.4% of patients. Safety was demonstrated with a 98.8% rate of freedom from clinical perforation at the time of the procedure, stated Boston Scientific.

“CTOs are very challenging, requiring additional time, resources, and patient exposure to imaging contrast and radiation,” commented Jihad A. Mustapha, MD. “The TruePath device is an exciting new technology that allows me to effectively penetrate these difficult blockages with greater speed and ease, allowing access to untreated lesions and helping to improve overall patient outcomes.”