February 9, 2012 — Boston Scientific announced the United States launch of 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 United States 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 difficult to treat with standard endovascular devices such as guidewires and other catheter-based technologies. They 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 ultra-low 0.018 inch 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.
"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," said Jeff Mirviss, president of the Boston Scientific peripheral interventions division. "Addressing this growing health problem through the use of less-invasive devices could greatly improve patient care and ultimately save limbs."
The ReOpen clinical study evaluated the TruePath CTO Device in 85 patients with peripheral artery lesions. Study results demonstrated the device was 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 percent of patients, while improved post-procedure blood flow was demonstrated in 82.4 percent of patients. Safety was demonstrated with a 98.8 percent freedom from clinical perforation at the time of procedure.
An estimated 17.6 million Americans and more than 30 million people worldwide suffer from peripheral vascular disease, which is characterized by blockages in vessels of the lower limbs and associated with high rates of morbidity and mortality. CTOs are estimated to be present in approximately 40 percent of patients treated for symptomatic peripheral artery disease.
Boston Scientific acquired the TruePath technology through its acquisition of ReVascular Therapeutics Inc. in February 2011. The TruePath CTO Device has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and carries CE mark approval.
For more information: www.bostonscientific.com