The US Food and Drug Administration (FDA) has granted 510(k) clearance to Semprus BioSciences' vascular access catheter, designed to provide peripheral access to the central venous system.
Using Semprus Sustain technology, the CE-marked Nylus peripherally inserted central catheter (PICC) provides access for infusion, intravenous therapy, blood sampling, central venous pressure monitoring and power injection of contrast media.
The catheter also incorporates a modified, long-lasting polymer surface to reduce the attachment of platelets and blood proteins at the surface of the device.
Semprus, a subsidiary of Teleflex Incorporated, said in both in vitro and acute animal testing, the PICC has shown to reduce platelet adhesion and thrombus accumulation by 99%.
Teleflex Incorporated chairman, president and CEO 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."
Semprus BioSciences VP and co-founder David Lucchino said, "With both U.S. and European market clearance, we are advancing a new standard of care for PICC catheters, in which improved patient outcomes and lower health care costs creates a win-win situation for patients and the healthcare delivery system."