Initial clinical experience with a new self-expanding nitinol stent for the treatment of intracranial cerebral aneurysms: the Cordis Enterprise stent

Abstract

Background and purpose: A new neurovascular microstent, the Cordis Enterprise stent, composed of nitinol, with a closed cell design, was specifically developed for the treatment of wide-necked intracranial cerebral aneurysms. The purpose of this study was to evaluate the safety, feasibility, and initial clinical results of using this device in patients.

Methods: In clinical evaluation, five patients ranging in age from 54 to 71 years were electively treated. The smallest aneurysm measured 3.3 x 2.9 mm, and the largest aneurysm measured 10.6 x 8.5 mm (neck and height measurements).

Results: All five cases (100%) were technically successful without complications. In each case, the stent was accurately placed in the desired location, immediately followed by coil embolization to the desired degree of occlusion with a satisfactory result. The poststent and coil-occlusion angiogram demonstrated excellent blood flow across the stent, with satisfactory positioning of the coils within the aneurysm in all cases (100%). No patient suffered any clinical or neurologic complications, and all were discharged 1-3 days postprocedure, in stable condition with no new neurologic deficits.

Conclusion: In early clinical studies, the Cordis Enterprise stent performed well. The stent was able to be well visualized, deployed easily, could be repositioned if needed, and was accurately placed without technical difficulties. The closed cell design allowed all coils to be placed within the aneurysm and remain outside the flow of the parent artery. No periprocedural complications were encountered.

Fig 1.

Cordis Enterprise stent, a nitinol, self-expanding, microstent with a closed-cell design. When fully expanded, it is 4.5 mm in its central portion. The distal ends flare out, and each end has four radiopaque markers for enhanced visibility.

Fig 2.

A, Posterior communicating artery aneurysm. Coil compaction with residual aneurysm filling. The neck width (arrows) is 5.5 mm and the dome height with residual aneurysm filling is 4.9 mm. B, Enterprise stent (arrows) is placed across the neck of the aneurysm in the supraclinoid internal carotid artery. C, Following stent placement and coiling, there is excellent blood flow across the stent and excellent coil occlusion of the aneurysm (arrow).

Fig 3.

A, Fusiform aneurysm of the distal vertebral artery (arrows) measuring 10.6 mm in length, with the posterior inferior cerebellar artery arising from the distal portion of the aneurysm (curved arrow). B, Enterprise stent has been placed across the aneurysm, a microcatheter (white arrow) is in the aneurysm, and a balloon (black arrows) is placed across the stent to ensure that the coils remain within the aneurysm and outside the parent artery. C, A total of eight Orbit coils were placed into the aneurysm, with occlusion of the lower two-thirds of the aneurysm and preservation of the upper one-third to preserve blood flow to the posterior inferior cerebellar artery (arrow).

Fig 4.

A, A 54-year-old woman presenting with recurrence of a giant distal basilar artery aneurysm. The base of the aneurysm incorporates both superior cerebellar arteries (small arrows) and the right posterior cerebral artery (large arrow). The left posterior cerebral artery is occluded. B, To maintain patency of both superior cerebellar arteries and the posterior cerebral artery, it was decided to place the stent 5 mm above the origin of the right posterior cerebral artery, directly within the aneurysm. The “white line” indicates stent deployment. C, Following stent deployment, a total of 13 additional Orbit coils were placed above the stent and were well maintained in position by the deployed stent. The postocclusion angiogram demonstrates significant reduction in flow to the aneurysm, while maintaining sufficient blood flow to both superior cerebellar arteries (small arrows) and the posterior cerebral artery (large arrow) by the stent.