Tractus Vascular receives 510(k) clearance for its TractusTM CSC

Vascular diseases are commonly termed as any abnormal condition that arises in the blood vessels (veins and arteries) which can lead to severe disability or death. Currently, there are several treatment alternatives for this condition, but several pharma companies are still searching for novel breakthroughs for treating this condition. 

Tractus Vascular LLC recently made some strides when it announced receiving a 510(k) clearance for its TractusTM Crossing Support Catheter (CSC) with lengths of 170 cm, 155 cm, 135 cm and 90 cm and with 0.035”, 0.018” and 0.014” guidewire compatibility.

For the record, TractusTM CSC is a highly novel treatment for vascular disease and is built for the purpose of using it during interventional procedures in the coronary and peripheral vasculature to maintain a guidewire as well as access in discrete regions, offer a channel for delivering contrast media and saline solutions, and permit guidewire exchanges.

Moreover, with most CSC being built with a braided sheath, Tractus provides its Jigsaw TechnologyTM laser cut stainless-steel shaft that includes a continuous helical cut pattern developing interlocking teeth.

Speaking on the clearance, Janet Burpee, Chairman and CEO/CTO, Tractus said that obtaining the FDA’s approval marks as one of many milestones in developing market technology that leverages economies in current catheter laboratories while always concentrating on user needs and patient outcomes.

Reportedly, Tractus Vascular was earlier built from an incubator firm, Tinker Med, LLC, which was originally a fully owned subsidiary of Burpee MedSystems, LLC. Commenting on this, Burpee said that, with Burpee MedSystems’ sale, Tinker Med could concentrate more on its firms that include Venarum Medical and Tractus Vascular.

Incidentally, medical device company Medtronic plc has also made significant development in the field of vascular disease when it revealed that it has obtained Breakthrough Device designation for its Valiant® TAAA Stent Graft System from the U.S. FDA. 

Reportedly, the platform is used for repair of TAAA (thoracoabdominal aortic aneurysm), a complex issue that causes bloating of the aorta, that spreads from the chest to the abdomen, with minimally invasion.

Source Credit: https://www.businesswire.com/news/home/20191102005020/en/Tractus-Crossing-Support-Catheter-Jigsaw-TechnologyTM-Receives