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Brain Aneurysms
A brain aneurysm (also known as an intracranial aneurysm) is a weak spot on a blood vessel in the brain that bulges out and fills with blood. Brain aneurysms vary in size, shape and location and can occur in anyone, at any age although they are more common in adults than in children. People with certain inherited disorders are also at higher risk.

Aneurysms may rupture and bleed into the brain, causing serious complications, including hemorrhagic stroke, permanent nerve damage, or death if left untreated. Most brain aneurysms go unnoticed until they rupture or are diagnosed by brain imaging that may have been obtained for another condition.

Prevalence
It is estimated that 1.5 to 5 percent of the general population has or will develop a brain aneurysm. Between 3 to 5 million people in the United States alone have brain aneurysms, but most do not produce any symptoms. Approximately 80% of patients who have aneurysms have one aneurysm, approximately 15% have 2 aneurysms and 5% have 3 or more aneurysms. Todays market for endovascular treatment of aneurysms is $900M, primarily in detachable coils. The potential for this market is projected to be > $2B. Coiling procedures are growing in the US alone by at least

10% per year driven by conversion of surgical clipping procedures. The clinical data in support of endovascular therapy has led to a broader acceptance of coiling. As a result, many neurosurgeons are being trained to perform endovascular therapy. This migration is further supported by existing reimbursement for aneurysm embolization devices. Due to the limitations of current aneurysm embolization devices, like coils, there exists opportunity for continued innovation in this area.

Diagnosis
There are several diagnostic methods available to detect and provide information about brain aneurysms.

Diagnostic cerebral angiogram. An intracerebral angiogram can detect the degree of narrowing or obstruction of an artery or blood vessel in the brain, head, or neck, and can identify changes in an artery or vein such as a weak spot like an aneurysm. It is used to diagnose stroke and to precisely determine the location, size, and shape of a brain tumor, aneurysm, or blood vessel that has bled. This test is slightly more invasive and less comfortable, but it is the most reliable way to detect all types and sizes of cerebral aneurysms.

Computed tomography (CT) of the head is a fast, painless, noninvasive diagnostic tool that can reveal the presence of a brain aneurysm and determine, for those aneurysms that have ruptured, if blood has leaked into the brain.

Magnetic resonance imaging (MRI) uses computer-generated radio waves and a powerful magnetic field to produce detailed images of the brain and other body structures. Magnetic resonance angiography (MRA) produces more detailed images of blood vessels. The images may be seen as either three-dimensional pictures or two-dimensional cross-slices of the brain and vessels. These painless, noninvasive procedures can show the size and shape of an unruptured aneurysm and can detect bleeding in the brain. To learn more, please visit Diagnosing Stroke or Symptoms/Diagnosis.

Current Therapies

Current therapy options for treating brain aneurysms include surgery (clipping) and intravascular coiling through a catheter. Of the two, surgery is considered to be more traumatic , but curative. Coil has been shown to be safer but has been plagued with a high rate of recurrence which frequently requires additional procedures.
1,2 1,2

A number of studies, including the ISAT Study , have shown that intravascular coiling of aneurysms causes less mortality and morbidity than surgery making it
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todays intravascular gold standard. However, the following limitations leave room for improvement and an opening for the LUNA to make a considerable difference in how aneurysms are treated.
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Challenges of coiling aneurysms: Retreatment Neurologic sequelae Compaction Aneurysm regrowth Perforation/rupture
References 1. 2. Molyneux A, Kerr R, et al. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms; a randomized trial. Lancet. 2002; 360 (9342): 1267-74. Molyneux A, Kerr R, et al. International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms; a randomized comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion. Lancet. 2005; 366 (9488): 809-817. Fiorella D, Kelly ME, etal. Curative Reconstruction of a Giant Midbasilar Trunk Aneurysm with the Pipeline Embolization Device. Neurosurgery. 2009; 64: 212-217. Sluzewski M, van Rooij WJ, et al. Late rebleeding of ruptured intracranial aneurysms treated with detachable coils. AJNR Am J Neuroradiol. 2005; 26 (10): 2542-2549. Park HK, Horowitz M, et al. Periprocedural morbidity and mortality associated with endovascular treatment of intracranial aneurysms. AJNR Am J Neuroradiol. 2005; 26 (3): 506-514. Soeda A, Sakai N, et al. Thromboembolic events associated with Guglielmi detachable coil embolization of asymptomatic cerebral aneursysms: evaluation of 66 consecutive cases with use of diffusion-weighted MR imaging. AJNR Am J Neuroradiol. 2003; 24 (1): 127-132. Bavinski G, Killer M, et al. Treatment of basilar artery bifurcation aneurysms by using Guglielmi detachable coils: a 6-year experience. J Neurosurg. 1999; 90 (5): 843-852. Kawanabe Y, Sadata A, et al. Endovascular occlusion of intracranial aneurysms with Guglielmi detachable coils: correlation between coil packing density and coil compaction. Acta Neuorochir (Wien). 2001; 143 (5): 451-455. Fulkerson DH, Horner TG, et al. Results, outcomes, and follow-up of remnants in the treatment of opthalmic aneurysms: a 16-year experience of a combined neurosurgical and endovascular team. Neurosurgery. 2009; 64 (2): 218-29. Islak C, Kocer N, et al. Endovascular management of basilar artery aneurysms associated with fenestrations. AJNR Am J Neuroradiol. 2002; 23 (6): 958-964. Sluzewski M, Bosch JA, van Rooij WJ, et al. Rupture of intracranialaneurysms during treatment with Guglielmi detachable coils: incidence,outcome, and risk factors. J Neurosurg 2001;94:238240.

13-59.1% 23-40% 10-39% 11%

9,10 5,6

3,4

7,8

2.5-8%
5

5,11

Lost coil; undesired embolization 1.7%

3. 4. 5. 6.

7. 8. 9. 10. 11.

LUNA

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The Problem: Cases using intravascular therapies like detachable

coils are long, multi-staged, require extensive training, huge inventories and have high retreatment.

The LUNA Objective: Deploy...Detach...Done.

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Designed to be delivered through standard industry catheters, LUNA is intended to be used to embolize (stop blood flow) brain aneurysms in a single deployment. It is detachable on demand to allow physicians to properly size and locate the device prior to leaving it behind as an implant.