Boston Scientific has introduced the TruePath™ CTO device in the US, designed to facilitate the crossing of chronic total occlusions (CTOs, or complete blockages) within the peripheral vasculature.
The FDA-cleared and CE-marked TruePath CTO device comprises a rotating diamond-coated tip intended to break through occluded peripheral arteries and allow the placement of conventional guidewires for treatment of peripheral lesions.
The ultra-low 0.018in profile and the rotating distal tip will enable drilling through calcified lesions and other fibrous blockages. An optional extension wire facilitates catheter exchange and increases the working length beyond 300cm.
J. A. Mustapha, director of endovascular intervention at Metro Health Hospital in Wyoming, MI, said, "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."
Boston Scientific Peripheral Interventions Division president Jeff Mirviss commented, "The TruePath device is another example of innovation in our priority growth area targeting peripheral vascular disease, where a significant number of patients remain undiagnosed or untreated."
The ReOpen clinical study in 85 patients with peripheral artery lesions has demonstrated that the TruePath CTO device is safe and effective in facilitating the crossing of intraluminal CTOs following resistance or prior failed attempts with a conventional guidewire. In the trial, 80% of patients achieved technical success, 82.4% of patients showed improved post-procedure blood flow and 98.8% demonstrated freedom from clinical perforation at the time of procedure.
In February 2011, Boston Scientific acquired the TruePath technology through its takeover of ReVascular Therapeutics. The company anticipates marketing of the product immediately in the US and plans to launch the product in Europe and other international markets in the first half of 2012.