Boston Scientific announced the US launch of the TruePath CTO device, designed to facilitate the crossing of chronic total occlusions (CTOs) within the peripheral vasculature.
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 ultra-low 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. This 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.
“Chronic total occlusions are very challenging, requiring additional time, resources and patient exposure to imaging contrast and radiation,” said J A Mustapha, director of Endovascular Intervention, Metro Health Hospital in Wyoming, USA. “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 ReOpen clinical study evaluated the TruePath CTO device in 85 patients with peripheral artery lesions. Study results demonstrated the device is safe and effective in facilitating the crossing of intraluminal CTOs following resistance or prior failed attempts with a conventional guidewire. In the study, technical success (defined as facilitation of CTO crossing) was achieved in 80.0% of patients, while improved post-procedure blood flow was demonstrated in 82.4% of patients. Safety was demonstrated with a 98.8% freedom from clinical perforation at the time of procedure.
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 US Food and Drug Administration (FDA) and carries CE mark approval.
The company expects to launch the product in Europe and other international markets in the first half of 2012.