Michael Barbella, Managing Editor08.17.23
Tractus Vascular LLC has won U.S. Food and Drug Administration (FDA) 510(k) clearance for its Tunnel Crossing Catheter (Tunnel CC).
The product's design enables superior and potentially best-in-class treatment of both arterial and venous occlusions, according to the company.
Tractus’ Jigsaw Technology shaft offers 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 FDA-cleared Tunnel CC family have 0.014”, 0.018” and 0.035” guidewire compatibilities and 90 cm, 135 cm, 155 cm, and 170 cm lengths.
This catheter design first received FDA 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."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," said Dr. Mahmood Razavi, who participated in Tractus CC's clinical user needs assessment. "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 performed the first-in-man evaluations. Tunnel CC's clinical evaluations—focusing on venous applications—began this quarter.
Tractus creates catheter products that treat 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 push force is needed. Tractus was created from incubator company Tinker Med LLC (formerly known as Burpee MedSystems LLC).
The product's design enables superior and potentially best-in-class treatment of both arterial and venous occlusions, according to the company.
Tractus’ Jigsaw Technology shaft offers 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 FDA-cleared Tunnel CC family have 0.014”, 0.018” and 0.035” guidewire compatibilities and 90 cm, 135 cm, 155 cm, and 170 cm lengths.
This catheter design first received FDA 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."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," said Dr. Mahmood Razavi, who participated in Tractus CC's clinical user needs assessment. "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 performed the first-in-man evaluations. Tunnel CC's clinical evaluations—focusing on venous applications—began this quarter.
Tractus creates catheter products that treat 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 push force is needed. Tractus was created from incubator company Tinker Med LLC (formerly known as Burpee MedSystems LLC).