Tractus Vascular Marks First Human Use of its Support Catheter
Tractus Vascular LLC is marking a milestone—the first-in-man use of its Tractus Crossing Support Catheter (Tractus CSC), a novel approach to treating vascular disease.
Chronic total occlusion (CTO) remains one of the most challenging pathologies encountered by surgeons and interventionalists in performing endovascular interventions. Drs. John H. Rundback and Kevin Herman of American Endovascular & Amputation Prevention in West Orange, N.J., both used the Tractus CSC to treat several patients with challenging cases of critical limb ischemia including CTOs. Dr. Rundback noted, “The Tractus catheter tracked like ice and performed exceptionally well; the cases were all extremely successful.”
The Tractus CSC received 510(k) clearance from the U.S. Food and Drug Administration 510(k) for 0.014-inch, 0.018-inch, and 0.035-inch guidewire compatibility and lengths of 90, 135, 155 and 170 cm. While most crossing support catheters are constructed with a braided sheath, Tractus offers its Jigsaw Technology laser cut stainless steel shaft consisting of a continuous helical cut pattern forming interlocking teeth. Distal “gusset cuts” offer a continuous stainless-steel tip which extends the attributes of this catheter shaft.
Tractus creates catheter products that excel in treating challenging CTOs and partial occlusions while matching the economies of today’s catheter lab. CTOs in the arterial vasculature are characterized by heavy arteriosclerotic plaque burden resulting in complete, or near complete occlusion of a vessel. CTOs in the venous vasculature, also known as chronic venous occlusion, is most common in the legs and is characterized by vein wall remodeling, collagenous fibrosis, and luminal reduction. 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, an ISO 13485 certified company, has received and is the process of receiving several regulatory approvals. Tractus was created from incubator company Tinker Med LLC.