March 1, 2017
To promote safe and effective use of medical devices, the FDA's Center for Devices and Radiological Health (CDRH) is clarifying the differences between neurovascular thrombus retrieval catheters and neurovascular guide catheters (e.g., intermediate catheter, distal access catheter). These devices are both cleared by FDA through the 510(k) premarket notification program. However, FDA premarket review and cleared indications for use for each of these devices are significantly different, and they also have possible differences in device design. We are highlighting these differences to help mitigate risks to patients.
What are FDA's device clearance processes for neurovascular thrombus retrieval catheters and neurovascular guide catheters?
|Neurovascular Thrombus Retrieval Catheters||Neurovascular Guide Catheters|
|FDA Product Code: NRY||FDA Product Code: DQY|
|Indications: Typically cleared with the indication for restoring blood flow or removal of thrombus within a blood vessel in the brain during an acute ischemic stroke within 8 hours of symptom onset in patients who are ineligible for or fail intravenous tissue plasminogen activator (IV t-PA) therapy.||Indications: Typically cleared with the indication of introducing interventional devices into the neurovasculature or as a conduit for retrievers.|
|Performance Data: Typically, clearance of neurovascular thrombus retrieval catheters for this type of indication is based on non-clinical (e.g., bench and animal) performance data and, when necessary, clinical performance data. CDRH reviews these data to evaluate the ability of the device to safely navigate into the tortuous neurovasculature in close proximity to the thrombus and remove the thrombus to revascularize the blood vessel.||Performance Data: Typically, clearance of neurovascular guide catheters for this type of indication is based on bench performance data to support the use of the catheter for the introduction of other interventional devices. Review of animal or clinical data is usually not required. In addition, neurovascular guide catheters are not reviewed for use in aspiration within the vessel for removing thrombus.|
What are the potential safety concerns associated with the use of neurovascular guide catheters as neurovascular thrombus retrieval catheters?
Neurovascular guide catheters and thrombus retrieval catheters may be designed with different features (e.g., length, diameter, variations in material stiffness distally and proximally). Use of neurovascular guide catheters for thrombus removal may affect the safety and performance, which could result in device failure and/or serious adverse events such as vessel damage, perforation, or dissection when used in the most distal regions of the neurovasculature.
The clinical complications of using neurovascular guide catheters for removal of thrombus may be attributed by the clinician to the disease state rather than to the use of these devices for thrombus removal, which could make recognition of device-related adverse events more difficult. Clinicians should be aware that the FDA has received a small number of adverse event reports associated with the use of neurovascular guide catheters for removal of thrombus, including a report associated with vessel perforation and death from a subsequent large subarachnoid hemorrhage.
Although the FDA has not cleared neurovascular guide catheters for thrombus removal in acute ischemic stroke patients, the FDA is aware of marketing materials and recently published literature that imply a new intended use for some neurovascular guide catheters for neurovascular thrombus removal in patients with acute ischemic stroke. The FDA will continue to be responsive to new technological advances and valid scientific evidence of new indications as part of our premarket review process.
Health care providers are encouraged to carefully consider the information provided above explaining the FDA cleared intended use when reading marketing materials and literature provided for guide catheters. It is also important for health care providers to be aware of, and consider, the differences in device design between cleared neurovascular guide catheters and neurovascular thrombus retrieval catheters and the potential implications those differences may have during certain uses, especially in the more distal regions of the neurovasculature.
How can I determine which devices have been cleared as neurovascular thrombus retrieval catheters or neurovascular guide catheters?
Information on which devices have been cleared as neurovascular thrombus retrieval catheters (FDA product code NRY) and neurovascular guide catheters (FDA product code DQY) can be accessed using the FDA's 510(k) Premarket Notification Database. You can also contact the device manufacturer or refer to the cleared indications for use in the device labeling.
If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-1000.
William Maisel, MD, MPH
Deputy Center Director for Science
Center for Devices and Radiological Health
U.S. Food and Drug Administration