Teleflex, a medical device manufacturer based in Limerick, Pennsylvania, recently received 510(k) clearance from the United States Food and Drug Administration for its Nylus PICC medical device. The new product by the Semprus BioSciences subsidiary is a peripherally inserted central catheter and features the Semprus Sustain technology platform.
The Nylus PICC is designed to provide surgeons with peripheral access to central veins in the body. This can be a valuable tool for infusion therapy, blood sampling, intravenous therapy, power injection of contrast media and central venous pressure monitoring. According to data from clinical trials, the Nylus peripherally inserted central catheter successfully reduced the adhesion of platelets. In addition, the device is able to reduce thrombus accumulation by an estimated 99 percent in acute animal testing and in vitro testing.
In a prepared statement, Teleflex CEO and president Benson Smith said, "Teleflex is pleased to obtain FDA clearance for the Nylus PICC, which is the first generation of the Semprus Sustain platform technology to move through the FDA 510(k) process." He continued, "We continue to be excited about the technology's potential to reduce thrombus-related complications for patients in a variety of applications."
The Nylus peripherally inserted central catheter received CE Mark approval from the European Union in July of this year.