Access Vascular’s HydroPICC Biomaterial-Based Dual-Lumen Catheter Cleared by FDA

May 5, 2022—Access Vascular, Inc. (AVI) announced that it has received FDA 510(k) clearance for the company’s HydroPICC dual-lumen peripherally inserted central catheter (PICC), which is a 5-F catheter available in multiple kit configurations. The device will be made available in the coming weeks.

According to AVI, the device is designed and constructed using the company’s hydrophilic biomaterial that is used in its single-lumen HydroPICC and HydroMID midline catheters and showed significant reduction in complications such as occlusions, replacements, deep vein thrombosis, and phlebitis in recent studies. The company’s hydrophilic biomaterial catheters mimic the body’s chemistry to reduce vascular access complications. Given the high utilization and complication rates of standard catheters, the use of AVI devices can meaningfully improve patient outcomes.

AVI advised that 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. The findings were presented at AVA 2021, the Association for Vascular Access annual scientific meeting held virtually September 16-19.

AVI plans to continue the expansion of its vascular access portfolio by adding more peripheral intravenous and central line options, stated the company.