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Tractus Crossing Support Catheter with its Jigsaw TechnologyTM Receives 510(k) Clearance


Tractus Vascular, LLC today announced the 510(k) clearance of the TractusTM Crossing Support Catheter (CSC) with 0.014, 0.018 and 0.035 guidewire compatibility and lengths of 90, 135, 155 and 170 cm. The TractusTM CSC represents a highly novel approach to treating vascular disease. While most crossing support catheters are constructed with a braided sheath, Tractus offers their Jigsaw TechnologyTM 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 novel catheter shaft.

The TractusTM CSC is intended to be used during interventional procedures in the peripheral and coronary vasculature to support a guidewire and facilitate access in discrete regions, allow for guidewire exchanges, and provide a conduit for delivering saline solutions and contrast media. Tractus Chairman and CEO/CTO, Janet Burpee, said This FDA clearance is the first of many milestones in bringing to market technology that capitalizes on the economies in todays catheter laboratories while always prioritizing patient outcomes and user needs.

Tractus Vascular, LLC was created from incubator company Tinker Med, LLC. Tinker Med was originally a wholly owned subsidiary of Burpee MedSystems, LLC. Janet Burpee added, With the sale of Burpee MedSystems, Tinker Med can now focus all efforts on its own companies which include Tractus Vascular and Venarum Medical.


About Tractus Vascular, LLC

Chronic total occlusion (CTO) remains one of the most challenging pathologies encountered by surgeons and interventionists in performing endovascular interventions. CTO in the arterial vasculature is characterized by heavy arteriosclerotic plaque burden resulting in complete, or near complete occlusion of a vessel. The reported rate of CTO in patients who undergo treatment of symptomatic peripheral artery disease (PAD) is approximately 40% and is cited as one of the primary reasons for procedural failures. CTO 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 is dedicated to creating catheter products that excel in the treatment of challenging lesions while moderating unit cost. Tractus intends to use its Jigsaw TechnologyTM to expand its product family of crossing devices.

Janet Burpee, CEO

Tractus Vascular, LLC

(732) 590-1470

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