Tractus Crossing Support Catheter with its Jigsaw TechnologyTM Receives 510(k) Clearance
EATONTOWN, N.J.--(BUSINESS WIRE)--Nov 2, 2019--
Tractus Vascular, LLC today announced the 510(k) clearance of the Tractus TM Crossing Support Catheter (CSC) with 0.014”, 0.018” and 0.035” guidewire compatibility and lengths of 90, 135, 155 and 170 cm. The Tractus TM 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 Technology TM 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 Tractus TM 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 today’s 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 Technology TM to expand its product family of crossing devices.
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CONTACT: Janet Burpee, CEO
Tractus Vascular, LLC
KEYWORD: NEW JERSEY UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: FDA HEALTH MEDICAL DEVICES
SOURCE: Tractus Vascular, LLC
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PUB: 11/02/2019 12:21 PM/DISC: 11/02/2019 12:21 PM