Boston Scientific has launched its TruePath CTO Device in the U.S. with a rollout in Europe scheduled for later in the year. TruePath is designed for penetrating through chronic total occlusions that block peripheral arteries, avoiding the need for the patient to undergo a bypass.
The device features a diamond coated tip that can spin at 13,000 rpm to drill right through uncooperative plaque buildups.
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. 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 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 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.
Here are a couple videos of the TruePath, including a product overview and an animation of the procedure:
Product page: TruePath…