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In vitro performance of a shape memory polymer foam-coated coil embolization device
Anthony J Boyle1, Mark A Wierzbicki1, Scott Herting2
1Department of Biomedical Engineering, Texas A&M University, College Station, TX, USA; Shape Memory Medical, Inc., College Station, TX, USA.
Medical Engineering & Physics
|August 5, 2017
Summary
A novel shape memory polymer foam-coated coil (FCC) shows promise for treating brain aneurysms. This new device offers improved packing density and tissue healing, potentially reducing recurrence and rupture risks.
Area of Science:
- Biomedical Engineering
- Neurosurgery
- Materials Science
Background:
- Intracranial saccular aneurysms pose a significant rupture risk.
- Current endovascular embolization devices face limitations, including aneurysm recurrence.
- Improved packing density and tissue healing are crucial for effective aneurysm treatment.
Purpose of the Study:
- To design and evaluate a novel shape memory polymer (SMP) foam-coated coil (FCC) embolization device.
- To assess the feasibility of FCC devices for clinical treatment of intracranial saccular aneurysms.
- To compare FCC device performance against current commercial devices regarding packing density and tissue healing.
Main Methods:
- Fabrication of FCC embolization devices.
- In vitro testing of FCC devices for delivery through tortuous pathways.
- Evaluation of working time for clinical repositioning during deployment.
- Pilot verification tests for particulates, chemical leachables, and cytocompatibility.
- Implantation of FCC devices in an in vitro saccular aneurysm model.
Main Results:
- FCC devices demonstrated smooth delivery comparable to control devices.
- FCC devices exhibited a working time exceeding 10 minutes for repositioning.
- Devices successfully passed pilot verification tests for safety and biocompatibility.
- Successful implantation in an in vitro aneurysm model achieved high packing density.
Conclusions:
- The FCC device shows effective delivery and packing performance for intracranial saccular aneurysms.
- FCC devices hold promise for improving treatment outcomes by increasing packing density and promoting tissue healing.
- Further studies are needed to evaluate device stiffness for optimal clinical application.
