Optimized for Crossing Venous and Arterial Occlusions: Tunnel™ Crossing Catheter Receives US FDA 510(k) Clearance

Despite World-Wide Supply Chain and Other Economic Challenges, Tractus Persevered to Offer a True Next Generation Crossing Catheter

EATONTOWN, N.J., June 07, 2023--(BUSINESS WIRE)--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.

About Tractus Vascular, LLCTractus is dedicated to creating catheter products that excel in the treatment of challenging partial and total occlusions while matching the economies of today's catheter lab. Chronic venous occlusions are most common in the legs and are characterized by vein wall remodeling, collagenous fibrosis, and luminal reduction. Chronic total occlusions in the arterial vasculature are characterized by heavy arteriosclerotic plaque burden resulting in complete, or near complete occlusion of a vessel. Tractus intends to use its Jigsaw Technology™ to expand its product family of crossing devices especially where maximum buckling resistance, and therefore push force is needed. Tractus was created from incubator company Tinker Med, LLC (fka Burpee MedSystems, LLC).

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Contacts

Janet Galtes, CEOformerly known as Janet Burpee Tractus Vascular, [email protected] (732) 590-1470