Boston Scientific has launched the TruePath CTO device, designed to facilitate the crossing of chronic total occlusions (CTOs, or complete blockages) within the peripheral vasculature. The company will begin marketing the product immediately in the U.S. and expects to launch the product in Europe and other international markets in the first half of 2012.
CTOs, which represent complete artery blockages, are extremely difficult to treat with standard endovascular devices such as guidewires and other catheter-based technologies. CTO devices permit endovascular treatment in cases that otherwise might require a patient to undergo bypass surgery or risk lower extremity amputation.
"CTOs are very challenging, requiring additional time, resources and patient exposure to imaging contrast and radiation," said J. A. Mustapha, M.D., director of endovascular intervention at Metro Health Hospital in Wyoming, Mich. "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."
The TruePath CTO device features a rotating diamond-coated tip designed to break through occluded peripheral arteries and facilitate the placement of conventional guidewires for treatment of peripheral lesions. The 0.018" profile is roughly half the size of competitive devices and is engineered for optimal crossing. Once positioned, the distal tip rotates at 13,000 rpm to facilitate drilling through calcified lesions and other fibrous blockages. 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.
Boston Scientific acquired the TruePath technology through its acquisition of ReVascular Therapeutics in February 2011. The TruePath CTO device has received 510(k) clearance from the FDA and carries CE mark approval.