Tractus Vascular has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Tunnel Crossing Catheter (Tunnel CC).
The Tunnel CC features a unique design that allows it to provide better and potentially best-in-class treatment for both arterial and venous occlusions.
Tractus plans to leverage its Jigsaw Technology to extend its crossing device portfolio, particularly in situations where maximum resistance to buckling and enhanced push force are required.
The Tunnel CC catheter family, cleared under 510(k), offers compatibility with 0.014", 0.018" and 0.035" guidewires. It comes in lengths of 90cm, 135cm, 155cm and 170cm.
Initially, this catheter design obtained 510(k) clearance as a Tractus crossing support catheter.
According to the company, positive clinical feedback was received on the catheter’s trackability, flexibility and ability to cross difficult occlusions.
Dr Mahmood Razavi, who was involved in the clinical user needs assessment of the catheter, said: “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 optimise the luer used for the smaller sizes to assure straightforward guidewire exchange. Overall, I am quite supportive of this technology.”
The commencement of clinical assessments for the Tunnel CC, with a specific focus on venous applications, is scheduled to commence in the third quarter of this year.
