FDA warns on stents associated with stent-assisted neurovascular coiling procedures

The FDA today warned about risks associated with the use of neurovascular stents used in stent-assisted coiling procedures after receiving a number of reports that suggest possible associations between peri-procedural stroke or death with the use of the devices.

The federal watchdog warned of procedural risks or patient selection related health factors associated with the use of the neurovascular stents, including the use of such devices with patients who have serious co-morbidities which can result in reduced life expectancy, or patients who are intolerant to required anti-coagulant or anti-platelet therapy.

To avoid events such as stroke or death, the FDA suggested that physicians discuss benefits and risks of neurovascular stent devices and procedures with patients as well as alternatives. This includes the possibility of the risks of treatment outweighing the benefits for smaller brain aneurysms and for patients with reduced life expectancy, the agency said.

The federal watchdog suggested physicians using such devices be aware that such devices are approved for treating brain aneurysms with limited characteristics and parent vessel sizes, and that the agency has not evaluated the safety and probable benefit outside those parameters.

The FDA also advised against the use of such devices in patients who aren’t candidates for systemic anticoagulation or who are not able to receive anti-platelet medications, as such devices generally require them peri-procedurally.

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