CereVasc completes first eShunt procedure in U.S.

CereVasc announced today that it completed the first procedure with the eShunt device in the U.S. as part of a pilot study.

Boston-based CereVasc’s first eShunt procedure was completed as part of a U.S. pilot study of the system in normal pressure hydrocephalus (NPH) being conducted under FDA investigational device exemption (IDE). Approval for the trial came from the FDA in February.

Dr. Charles Matouk, associate professor of neurosurgery, vice chair of clinical affairs for neurosurgery and chief of neurovascular surgery at Yale Medicine, treated the patient.

“We are pleased to participate in this study of the eShunt System, a promising device with the potential to transform the care of patients with NPH using a minimally invasive approach as opposed to open surgery,” Matouk said in a news release.

CereVasc Chair and CEO Dan Levangie added: “This study, which will evaluate the safety and efficacy of the eShunt System, repr…

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FDA approves second IDE study for CereVasc eShunt

CereVasc announced today that it received a second FDA investigational device exemption (IDE) for its eShunt system.

The IDE allows CereVasc to initiate a pilot trial of the eShunt system in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage (paSAH). The company received its first IDE to begin a trial of the eShunt for normal pressure hydrocephalus in February.

“We are excited to receive IDE approval from FDA to conduct a second pilot study in the U.S. of the eShunt system in patients who develop hydrocephalus following subarachnoid hemorrhage,” CereVasc Chair and CEO Dan Levangie said in a news release. “Enrolling in parallel with our first IDE study in patients with normal pressure hydrocephalus (NPH), this study will allow us to further examine the safety and efficacy of the eShunt System in a second etiology of hydrocephalus, both of which present a number of management challenges to physicians.”…

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CereVasc wins FDA IDE approval to begin eShunt pilot study

CereVasc today announced that it received an FDA investigational device exemption approval to begin a trial of the eShunt for normal pressure hydrocephalus.

The Boston-based company can initiate its pilot trial of the eShunt system in patients with normal pressure hydrocephalus (NPH). The eShunt device offers a minimally invasive treatment with the potential to result in benefits over the current gold-standard treatment.

Get the full story on our sister site, Medical Tubing + Extrusion.

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CereVasc successfully performs first-in-human procedure with eShunt system

CereVasc announced today that it completed the first treatment with its eShunt system for treating communicating hydrocephalus (CH).

Boston-based CereVasc touts the eShunt as the first minimally invasive cerebrospinal fluid shunt and delivery technology designed to avoid the need for invasive surgery and extended hospitalization associated with the current surgical treatment of hydrocephalus.

The company said in a news release that it designed the eShunt to offer improvements compared to the current treatment, a half-century-old neurosurgical procedure that is associated with frequent failure, infection risk and high costs.

Dr. Pedro Lylyk reported the first case as he conducts the first-in-human study of the eShunt system at Clinica la Sagrada Familia in Buenos Aires, Argentina. The ongoing trial will produce additional data in 2022, CereVasc said.

“Despite this being very early data, there is great significance in the first-ever treatment …

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CereVasc closes $43.9m Series A

Hydrocephalus treatment developer CereVasc announced today that it closed an expanded Series A financing round, raising a total of $43.9 million.

The Perceptive Xontogeny Venture (PXV) Fund and ATON Partners led the funding round, according to a news release.

CereVasc intends to use the raised proceeds to support the first-in-human clinical trial for its eShunt system, along with follow-up for clinical studies to support regulatory approvals. The first study is expected to start enrollment during the second half of this year.

The Boston-based company touts its eShunt system as the first minimally invasive cerebrospinal fluid shunt and delivery technology designed to avoid the need for invasive surgery and extended hospitalization associated with the current surgical treatment of hydrocephalus.

“With this financing, we are well-positioned to drive the development of our eShunt System forward as we strive to improve care for patients with hydrocepha…

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