Tractus Vascular, LLC today announced 510(k) clearance of the Tunnel™ Crossing Catheter (Tunnel™ CC). The unique design of the Tunnel CC enables superior and potentially best-in-class treatment of both arterial and venous occlusions.
Tractus’ novel Jigsaw Technology™ shaft offers remarkably high buckle resistance, yielding superior pushability across difficult occlusions. Its’ continuous jigsaw pattern is helically laser cut from a stainless-steel tube creating interlocking teeth. Distal “gusset cuts” create a continuous stainless-steel tip further enhancing the attributes of this novel catheter shaft. The 510(k) cleared Tunnel™ CC family of catheters have 0.014”, 0.018” and 0.035” guidewire compatibilities and lengths of 90, 135, 155 and 170 cm.
This catheter design first received 510(k) clearance as Tractus™ Crossing Support Catheter (Tractus™ CSC). Clinical feedback on trackability, flexibility and ability to cross difficult occlusions has been extremely positive. Dr. Mahmood Razavi participated in the clinical user needs assessment. He commented, “I used this catheter on several occasions when another catheter could not successfully pass through an occlusion. In each case, the Tractus catheter was successful. The company intends to further optimize the luer used for the smaller sizes to assure straightforward guidewire exchange. Overall, I am quite supportive of this technology.” As previously announced, Dr. John Rundback successfully performed the first-in-man evaluations. Clinical evaluations of the Tunnel™ CC focusing on venous applications will begin in Q3 2023.
Source: Company Press Release
