Access Vascular, Inc. (AVI) today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its HydroPICC® Dual-Lumen catheter.
Designed and constructed using the same proprietary hydrophilic biomaterial as AVI’s single-lumen HydroPICC® and HydroMID® catheters, these devices showed significant reduction in complications such as occlusions, replacements, Deep Vein Thrombosis and phlebitis in recent studies.
“We are proud to announce FDA clearance for our HydroPICC Dual-Lumen catheter as the latest addition to our family of devices,” said Access Vascular CEO James Biggins. “Hospital patients experience unnecessarily high incidences of vascular access complications, largely because of the material used by competitive catheters. With roughly half of all PICC usage in hospitals attributed to dual-lumen devices, the availability of our biomaterial-based dual-lumen catheter means even more patients can now benefit from uninterrupted treatment and less risk of complications.”
A majority of hospital patients receive a vascular access device and 30% of those patients encounter a vascular access-related complication. Most are caused by the materials used in standard catheters, which trigger the body’s natural defenses and causes the build-up of platelets – or thrombus, leading to complications such as phlebitis, blood clots and infections.
AVI’s patented hydrophilic biomaterial catheters mimic the body’s chemistry to dramatically reduce these common and costly complications. Given the high utilization and complication rates of standard catheters, the use of AVI devices can meaningfully improve patient outcomes.
A reduction in complications can also have a positive impact on hospital economics. A recent study on the single-lumen HydroPICC® demonstrated a statistically significant reduction in complications such as occlusions and replacements compared to traditional catheters, resulting in a 50% avoidance of additional material costs.1
Access Vascular advises the HydroPICC Dual-Lumen is a 5 French catheter available in multiple kit configurations. It will be made available over the coming weeks as the newest addition to the expanding family of AVI vascular access devices. AVI plans to continue expansion of its portfolio by adding more peripheral intravenous and central line options.