The FDA has issued two new final guidance documents governing labels for a variety of intravascular devices.
One covers labels for intravascular catheters, wires, and delivery systems with lubricious coatings, and the other is for coronary, peripheral and neurovascular guidewires.
Intravascular devices with hydrophilic or hydrophobic coatings may offer physicians greater maneuverability within blood vessels, and may also protect patients from harm during procedures. They have also been associated with serious adverse events such as pulmonary or myocardial embolism or infarction, embolic stroke, tissue necrosis and death if the coatings separate from the devices.
Reports of such events spurred device recalls by companies including Cook Medical, Medtronic (NYSE:MDT) and SentreHeart. The FDA issued a safety communication on the topic in 2015.
When manufacturers produce new labels for these devices, the FDA wants them to prominently note the coating’s presence, briefly describe the coating and refer users to critical information about usage and safety.
The guidance covering coronary, peripheral and neurovascular guidewires covers devices used in placing therapeutic devices during percutaneous interventional procedures. It covers premarket submissions, predicate comparisons, biocompatibility, sterility and several other topics, including potential adverse events.
Original Article: (https://www.massdevice.com/new-fda-guidance-out-for-vascular-device-labels/)
