Access Vascular’s HydroMid Midline Catheter Receives FDA Clearance

February 11, 2021—Access Vascular announced FDA clearance of the company’s HydroMid midline catheter. The device will be made available over the next few weeks to gain clinical feedback on its usage.

HydroMid is a 4-F, single-lumen midline catheter with a maximum usable length of 20 cm. It is made of Access Vascular’s biomaterial, which has been shown to reduce thrombus accumulation by up to 97% when compared to standard polyurethane catheters. This is the second device in its planned portfolio to obtain clearance.

According to the company, midline catheters have grown in popularity due to inclusion in the Michigan appropriateness guide to intravenous catheters guidelines and the elimination of the need for confirmatory chest x-rays for midline placement. The company noted that standard midlines are composed of polyurethanes or silicones that may lead to protein adsorption, which can result in thrombus accumulation or catheter-related infections.

Access Vascular stated that its expansion into midlines enables health care professionals to choose either a midline or peripherally inserted central catheter made of this thrombus-resistant biomaterial, depending on their needs. Midlines, intended for use of up to 30 days, have the advantage of a generally higher level of patient comfort when compared to peripheral intravenous catheters because of a fewer number of restarts.

The release of the midline also furthers the company’s plans to develop a portfolio of thrombus-resistant venous catheters and devices composed of its proprietary biomaterial. The company’s first product, the HydroPICC, was cleared by the FDA in 2020 and is currently rolling out commercially in the United States with the focus of obtaining real-world clinical data.