Access Vascular Receives FDA Clearance for HydroPICC Catheter

The U.S. Food and Drug Administration (FDA) has granted Access Vascular Inc. (AVI) 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,” Access Vascular CEO James Biggins said. “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 percent 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 percent avoidance of additional material costs.¹ 
 
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.
 
Access Vascular was founded to address the most common and costly complications of intravenous therapy: infection, thrombosis, and phlebitis. Taking a foundationally different approach to thrombus reduction, the company manufactures intravenous catheters from a hydrophilic material which retains significant amounts of water.  Engineered to mimic the body’s natural chemistry, Access Vascular catheters are designed to evade the foreign body response and complications that come with it. The firm’s FDA-cleared products are HydroPICC and HydroMID.  

Reference
¹ Presented at AVA 2021. Data on file at Access Vascular Inc. Material costs include TPA and replacement PICC lines.  Assumes PICC line cost of $125. Calculation based on economic calculator, data on file.