The Tractus 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
Image: Tractus Vascular wins 510(k) clearance for Crossing Support Catheter.Photo: Courtesy of falco/Pixabay.
Tractus Vascular announced the 510(k) clearance of the Tractus 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 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 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 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 was created from incubator company Tinker Med. Tinker Med was originally a wholly owned subsidiary of Burpee Med Systems. Janet Burpee added, “With the sale of Burpee Med Systems, Tinker Med can now focus all efforts on its own companies which include Tractus Vascular and Venarum Medical.”
Source: Company Press Release