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O14 One-year safety of treating communicating hydrocephalus with the eShunt® implant
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  1. Pedro Lylyk1,
  2. Charles Matouk2,
  3. Howard Riina3,
  4. Adnan Siddiqui4,
  5. Ivan Lylyk1,
  6. Carlos Bleise1,
  7. Esteban Scrivano1,
  8. Pedro Lylyk1,
  9. Joseph Antonios2,
  10. Brandon Beneduce5,
  11. Elad Levy4,
  12. Carl Heilman6,
  13. Adel Malek6
  1. 1ENERI, Clinica La Sagrada Familia, Argentina
  2. 2Yale New Haven Hospital, New Haven, USA
  3. 3NYU Grossman School of Medicine, New York, USA
  4. 4University of Buffalo, SUNY, Buffalo, USA
  5. 5CereVasc, Inc., Charlestown, USA
  6. 6Tufts Medical Center, Boston, USA

Abstract

Introduction The eShunt Implant is a novel, endovascular cerebrospinal fluid (CSF) shunt developed to treat communicating hydrocephalus. The transdural Implant’s self-expanding anchor resides within the cerebellopontine angle subarachnoid cistern and tubular body resides within the inferior petrosal dural venous sinus, draining CSF into the internal jugular vein. A differential pressure valve allows 10 cc/hr CSF outflow at physiologic pressures and prevents backflow during transient retrograde pressure spikes.

Aim of Study We present safety results through one-year in the first series of treated patients.

Methods Patients across three different hydrocephalus etiologies were implanted: normal pressure hydrocephalus (NPH), intractable hydrocephalus post-aneurysmal subarachnoid hemorrhage (paSAH), and idiopathic intracranial hypertension (IIH). Radiologic evaluation by MR or CT and modified Rankin Scale (mRS) scoring occurred at one-year and was compared to baseline.

Results Fourteen treated patients completed one-year follow-up: nine NPH (4 female; mean 75.7+/-7.3 years), four paSAH (3 female; mean 57.5+/-16.5 years), and one IIH (1 male, 50 years). No observations of radiologic or symptomatic overdrainage occurred. No instances of procedural or delayed subarachnoid, intraparenchymal or subdural hemorrhage occurred. Cross-sectional imaging immediately post-operatively compared to one-year confirmed Implant stability without antegrade or retrograde migration. mRS scores were either stable or improved compared to baseline.

Conclusion The eShunt Implant was designed as a permanent implant to drain CSF into the venous system. These preliminary results indicate a potentially acceptable long-term safety profile for treating communicating hydrocephalus. A planned clinical trial will provide a comprehensive safety assessment in a large population of patients.

Disclosure of Interest yes BB, CH, AM- CereVasc shareholders.

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