Tractus Vascular’s Tunnel Crossing Catheter Cleared for Venous and Arterial Occlusions

June 7, 2023—Tractus Vascular, LLC announced 510(k) clearance of the Tunnel crossing catheter (Tunnel CC) for treatment of both arterial and venous occlusions.

According to the company, the device features Tractus’ Jigsaw shaft, which offers high buckle resistance for pushability across difficult occlusions. The continuous jigsaw pattern is helically laser cut from a stainless steel tube, creating interlocking teeth, and distal “gusset cuts” create a continuous stainless steel tip that enhances the attributes of the catheter shaft, describes Tractus in its announcement.

The FDA-cleared Tunnel CC family of catheters have 0.014-, 0.018-, and 0.035-inch guidewire compatibilities and lengths of 90, 135, 155, and 170 cm.

Mahmood Razavi, MD, who participated in the clinical user needs assessment, commented in the company’s press release, “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.”

Dr. Razavi continued, “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.”

This catheter design first received 510(k) clearance as the Tractus crossing support catheter.

In March 2022, Tractus Vascular announced that John H. Rundback, MD, successfully performed the first-in-human evaluations with the technology. Clinical evaluations of the Tunnel CC focusing on venous applications will begin in Q3 2023, advised the company.