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The Contour is a novel intra-aneurysmal flow disrupting device to treat intracranial aneurysms.To evaluate the safety and effectiveness of the Contour device for treatment of nonruptured intracranial bifurcation aneurysms through a prospective, multicenter, single-arm study.Thirty-four patients were enrolled. Primary end points were successful occlusion at 6 mo for efficacy and any major stroke or nonaccidental death up to 30 d or major disabling stroke within 6 mo for safety. Secondary end points were occlusion at 12 mo, retreatment rate, procedure time, and procedure-related/device-related adverse events. Procedural and follow-up imaging was reviewed by an independent core laboratory. Adverse events were reviewed and adjudicated by a clinical events committee.In total, 32 of 34 aneurysms were successfully implanted and, 2 of 34 in the intention-to-treat (ITT) group did not receive the Contour and were excluded from follow-up after 30 d. In addition, 2 of 32 were lost to angiographic follow-up and regarded as treatment failure. The primary safety end point was met in 2 patients in the ITT group. In the perprotocol (PP) group, complete occlusion was seen in 14 of 32 (44%) at 6 mo and 22 of 32 (69%) at 12 mo. Adequate occlusion (Raymond-Roy [RR] 1 and 2) was reached in 84% at a last available follow-up. One patient from the ITT group and 1 from the PP group received additional treatment during follow-up.The Contour seems to be both safe and effective in the treatment of intracranial bifurcation aneurysms.

OBJECTIVE: The treatment of space-occupying cystic lesions includes percutaneous cyst aspiration, marsupialization, percutaneous ventriculocystotomy, or Rickham catheter implantation. In some patients, the cysts tend to recur and repeated evacuations are necessary. The authors present a new treatment method with internal drainage of cysts into the ventricular system using a balloon-mounted vascular stent. METHODS: Six patients with cysts of low-grade gliomas, one with monocystic craniopharyngioma, and one with suprasellar arachnoid cyst were treated between September 2003 and May 2005. All patients were symptomatic after multiple previous treatments. Stent implantations were performed under local anesthesia in adults and under general anesthesia in children. In all patients, the stereotactic frame and computed tomographic and magnetic resonance fusion were used for an optimized approach. The treatment was performed in a compassionate manner and the patients were informed about the off-label use of the device. RESULTS: Stent placement was successful in all eight patients without procedure-related complications. Improvement of clinical symptoms was seen in seven out of eight patients. Seven out of eight cysts decreased in size within a follow-up period of up to 23 months (mean, 17 mo; median, 18 mo; range, 6-23 mo). The first patient showed recurrence of the tumor cyst 3 months after initial treatment with a Herkulink stent (5 × 18 mm), followed by retreatment with an Omnilink stent (6 × 28 mm; Guidant Corp., Santa Clara, CA). Stenting was ineffective in one patient. @@CONCLUSION:@@ Treatment of intracranial cystic lesions by internal drainage is possible with the use of stent-assisted ventriculocystostomy.