A Safety Net to Prevent Embolization during Interventional Procedures: Work in Progress1

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Abstract

PURPOSE:

In vitro evaluation of three prototype devices designed to trap emboli that are generated by intravascular procedures.

MATERIALS AND METHODS:

Three prototypes of the safety net were tested in a water flow model. Angioplasty of human endarterectomy specimens was performed upstream of the device (n = 8). In other tests, polyvinyl alcohol particles were injected into the water flow model upstream of the device (n = 15). The safety nets and the effluent that passed through them were examined for embolic particles. A third prototype was tested (n = 5) to evaluate whether the device could be deployed and retrieved as designed.

RESULTS:

The safety net was able to trap debris released by angioplasty of endarterectomy specimens in every case. Most, but not all, polyvinyl alcohol particles were trapped by the safety net. Four of five devices tested were deployed and retrieved as designed. One became caught in the introducing valve, which prevented deployment.

CONCLUSION:

The vascular safety net is effective in trapping small volumes of emboli. It can be deployed and retrieved as designed.

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