March 3, 2020
FDA Clears Access Vascular’s Next-Generation HydroPICC
March 3, 2020—Access Vascular, Inc. announced that it has received FDA clearance for the second generation of its HydroPICC peripherally inserted central catheter (PICC). The company will focus on generating clinical evidence at a limited number of commercial sites in the United States in 2020.
According to the company, HydroPICC is composed of Access Vascular’s biomaterial platform that combines the mechanical properties of polyurethanes with the low thrombogenicity of hydrogel. The lubricious and hydrophilic material is designed to repel protein and thrombus development, prevent catheter occlusion, reduce infections, and add flexibility to the catheter.
The second-generation device is easy insert and integrates new features that streamline placement time based on clinician feedback from the commercial experience of the first-generation catheter.
The company stated that the device has demonstrated a thrombus accumulation rate 30 times less than traditional PICCs and may potentially reduce catheter occlusions.
Gregory J. Schears, MD, who is Professor of Anesthesiology at Mayo Clinic in Rochester, Minnesota, and serves as a medical advisor to Access Vascular, commented in the company’s announcement, “The importance of improving the biocompatibility of materials that reside within the intravascular space cannot be overemphasized. Despite attention to optimal site choice and catheter to vein ratios, patients often develop fibrin sheaths that inhibit catheter functionality. They also commonly develop venous thrombus, sometimes with associated blood stream infections, that use these depositions as basecamps for biofilm formation. A material that could combat these issues has the potential to significantly improve vascular access throughout the body.”
Access Vascular plans to develop a variety of thrombus-resistant venous catheters and devices from the biomaterial for applications including midlines, peripherally inserted venous catheters, ports, central venous catheters, and dialysis catheters, the company noted.