May 7, 2018

FDA Issues Recommendations on Neurovascular Stents Used for Stent-Assisted Coiling of Unruptured Brain Aneurysms

May 8, 2018—The US Food and Drug Administration (FDA) has issued a letter to health care providers providing recommendations on patient selection and device use of neurovascular stents for stent-assisted coiling (SAC) of brain aneurysms. The recommendations are intended to promote the safe and effective use of the devices in this treatment. The letter by William Maisel, MD, Deputy Center Director for Science at the FDA Center for Devices and Radiological Health, is available online here.

As noted in the letter, the FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of periprocedural stroke and/or death that may have been related to procedural risks or patient selection. These selection-related factors include patients who had serious comorbidities resulting in a reduced life expectancy or who were intolerant to required anticoagulation or antiplatelet therapy.

There are well-established factors that are known to increase the risk of brain aneurysm rupture and should be considered in selecting appropriate patients for treatment with a neurovascular stent. These risk factors include: patient age, presence of symptoms, family history of brain aneurysm(s) or subarachnoid hemorrhage, previous subarachnoid hemorrhage, sex, ethnicity, tobacco use, hypertension, as well as brain aneurysm location, morphology, size, and changes over time of size and morphology.

In brief, the FDA recommends the following when using neurovascular stents for SAC:

  • Consider and discuss with patients the benefits and risks of neurovascular stent devices and procedures
  • Be aware that neurovascular stent devices for SAC are approved for the treatment of brain aneurysms of limited characteristics and parent vessel sizes
  • Avoid use of neurovascular stents for SAC in patients who are not candidates for systemic anticoagulation and/or not able to receive antiplatelet medications as use of the devices require periprocedural anticoagulation and/or antiplatelet therapy
  • Select a neurovascular stent for SAC of proper length and diameter based on the dimensions of the brain aneurysm and parent vessel
  • Only use delivery microcatheters that have been found compatible for use by the neurovascular stent manufacturer
  • Carefully observe microguidewires and microcatheters when they are manipulated within or passed through the struts of an implanted stent
  • Carefully observe embolization coils when they are manipulated within a brain aneurysm and avoid coil prolapse through stent struts
  • Ensure that the specific coil models and sizes chosen are indicated for the embolization of brain aneurysms

Finally, health providers are instructed to report any adverse events associated with neurovascular stents for SAC. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.


May 9, 2018

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May 3, 2018

Intact Vascular's TOBA III Trial Completes Enrollment in Europe