FDA Approval of Pipeline Device for Brain Aneurysms
The FDA approved the Pipeline Embolization Device for brain aneurysms in April 2011. 1
Background on the Pipeline Device
The Pipeline Embolization Device (PED) is a flow-diverting stent designed for the treatment of intracranial aneurysms. It represents a significant advancement in endovascular therapy, particularly for aneurysms that are challenging to treat with conventional methods.
Evolution of Endovascular Aneurysm Treatment
- 1990: Guglielmi Detachable Coil (GDC) introduced for clinical use 2
- 1995: FDA approved GDC for surgically unclippable aneurysms 2
- 2002: FDA approved Neuroform stent (Boston Scientific) for wide-necked cerebral aneurysms 2
- 2011: FDA approved Pipeline Embolization Device 1
Pipeline Device Applications and Efficacy
The Pipeline device is particularly beneficial for:
- Large or giant aneurysms
- Wide-necked aneurysms
- Previously treated aneurysms with recanalization
- Aneurysms in locations challenging for surgical access, especially posterior circulation 3
Clinical outcomes with the Pipeline device have been promising:
- Complete occlusion rates of 75% at 180 days and 85.5% at 1 year 4
- Low retreatment rate of 3% at mean follow-up of 10.2 months 4
- Acceptable safety profile when used with rigorous technique 1
Safety Considerations
While the Pipeline device has shown effectiveness, it's important to note the potential complications:
- Major ipsilateral ischemic stroke rate: 3.7% 4
- Major ipsilateral intracranial hemorrhage rate: 2.0% 4
- Combined major morbidity and neurological mortality rate: 7.1% 4
Some studies have reported higher rates of transient complications (28.6%) despite low permanent complication rates (3.2%), suggesting careful patient selection is crucial 5.
Post-Procedure Management
Patients receiving Pipeline devices require:
- Dual antiplatelet therapy to prevent thromboembolic complications
- Regular angiographic follow-up to assess aneurysm occlusion and device patency 3
The FDA approval of the Pipeline Embolization Device in 2011 marked an important milestone in the treatment of complex intracranial aneurysms, providing a valuable alternative for patients with aneurysms not amenable to conventional treatment methods.