CereVasc has treated a thirtieth patient with its eShunt implant. The procedure is part of ongoing pilot studies being conducted in the US and Argentina investigating the company’ less invasive therapy for the treatment of communicating hydrocephalus.
The US (NCT05501002) and Argentinian (NCT04758611) pilot studies involve patients with communicating hydrocephalus who cannot be weaned from an external ventricular drain following a haemorrhagic event.
After implantation, subjects will be evaluated every month for 90 days. Post-operative follow-ups at 180 days, 12 and 24 months will then be conducted. The primary outcome is the reduction in intracranial pressure.
The Boston, US-based medtech company is studying its eShunt implant under US Food and Drug Administration-approved investigational device exemption (IDE) and under regulatory approval by the National Administration of Drugs, Food and Medical Devices (ANMAT) in the US and America respectively.
CereVasc said it is planning to conduct a multicentre pivotal trial in 2024.
The eShunt system is an endovascularly implantable CSF shunt and a delivery system. The permanent implant, deployed in a minimally invasive procedure, is designed to drain excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space into the venous system.
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According to CereVasc, the procedure can take less than an hour, potentially allowing for a day-surgery alternative to the standard surgical treatment of a ventriculoperitoneal shunt. CereVasc also state that its implant is designed to eliminate the need for invasive incisions in the brain, including foregoing the requirement of passing a rigid catheter through the cortex.
The hydrocephalus shunt device market was worth $80m in 2022. It is expected to be worth $113m by 2033.
Dr Pedro Lylyk, general Director of the Comprehensive Stroke Center at Clinica la Sagrada Familia in Buenos Aires, Argentina, who performed the procedure said: “Providing patients with the option of a minimally invasive treatment for hydrocephalus could evoke a new paradigm in neurovascular surgery.”
CereVasc President & CEO Dan Levangie said: “The data generated by this robust body of clinical work will support the advancement of the eShunt System into a pivotal phase next year.”