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Since their introduction two decades ago, hydrophilic and hydrophobic coatings on intravascular devices such as catheters, wires, and delivery systems have proven highly popular for decreasing the frictional force when the devices are introduced into the vasculature. By reducing the force required to manipulate intravascular medical devices during vascular interventional procedures, these coatings reduce the risk of damage to blood vessel walls and prevent vasospasm.

According to the “Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations” draft guidance issued late last year, “(a)lthough these devices may offer patient benefits, recent evidence indicates that the coating may separate from intravascular devices in some circumstances. The FDA has received and analyzed information concerning serious adverse events associated with hydrophilic and/or hydrophobic coatings separating (e.g., peeling, flaking, shedding, delaminating, sloughing off) from intravascular medical devices. This information has included voluntary recalls of guidewires, sheaths, retrieval devices, and embolization device delivery wires, as well as Medical Device Reports (MDRs) describing separation of hydrophilic and/or hydrophobic coatings from medical devices such as guidewires, catheters, and introducers that have been used for cerebrovascular, cardiovascular, and peripheral vascular procedures.” While the FDA believes the overall benefits of these devices continue to outweigh the risks, it has issued these new labeling consideration guidelines for devices containing lubricous coatings used in vasculature.

This FDA regulatory compliance guidance document provides nonbinding labeling recommendations for both Class II and Class III devices such as intravascular catheters, wires, and delivery systems with lubricious coatings used in the vasculature. Due to higher risks that are associated with use of these devices in the neuro, coronary, and peripheral vasculature, FDA has focused the scope of this guidance on devices used in those vascular regions, although some of these considerations could be applicable to devices with similar coatings used in other types of interventional procedures. 

The guidance discusses several major labeling concerns, including:

Device Description
In addition to the device description currently provided, the labeling should include a statement to identify that the device is coated, as well as a brief description (e.g., hydrophilic, hydrophobic) of the coating, its location on the device (e.g., proximal or distal end), the length of the coating, and its purpose.

Indications for Use Statement
All indications for use described in the labeling should be supported by information in the premarket submission. For intravascular devices, this includes identifying any specific regions of the vasculature for which the device is cleared or approved for use.

Warnings, Precautions, and Preparation Steps
If information regarding safety is not available, or has not been established for indications other than those specified in the regulatory submission, it may be appropriate to consider the inclusion of a precaution statement reflecting such.

It is recommended that the labeling include any other specific considerations such as device compatibility, storage conditions, specific preparation steps, and any appropriate troubleshooting or tips that should be conveyed to the device user in order to enhance the safe use of the device.

Potential Adverse Events
Potential adverse events that could be attributed to coating loss should be described in the labeling. FDA acknowledges that the specific adverse events may depend on the specific design and intended use of the device.

The FDA has stated that this draft guidance, along with another guidance released simultaneously, provide industry and FDA staff with recommendations on the least burdensome means of assessing the performance of catheters, guidewires and delivery systems submitted in premarket approval applications (PMAs) or 510(k) premarket notifications. If you’re a manufacturer of Class II or Class III devices for use as set forth in this new guidance you should consider a medical device consulting firm such as MEDIcept to assist you with regulatory consulting as well as quality consulting, since these may become areas of potential concern with the new device labeling recommendations.