CereVasc Receives IDE Approval to Expand Study of Gen2 eShunt System in Patients With NPH

September 18, 2023—CereVasc, Inc. announced that the FDA has approved an investigational device exemption (IDE) supplement to permit the expansion of the study of the company’s second-generation (Gen2) eShunt system in patients with normal pressure hydrocephalus (NPH) to additional study participants and clinical sites.

The IDE supplement approval also allows for the use of the next-generation eShunt system in the NPH study.

According to the company, the Gen2 eShunt system has been designed to simplify the device preparation process and enhance the overall ease of use of the system, while maintaining eShunt implant performance.

“The early results we have seen in our pilot study of the eShunt system in treating patients with idiopathic NPH have been positive and we could not be more excited about the opportunity to have Generation 2 of the eShunt system evaluated in an expanded NPH pilot study in the United States,” stated Dan Levangie, CereVasc President and CEO, in the press release. “Our development team has thoughtfully incorporated feedback from our study investigators and our collaborators—Pedro Lylyk, MD; Carl Heilman, MD; and Adel Malek, MD, PhD—to improve the usability of the system without compromising functionality or patient safety and are looking forward to its use in the study.”

In related company news, CereVasc recently announced the presentation of data from a first-in-human clinical study conducted in Argentina that examined the investigational use of the eShunt system to treat communicating hydrocephalus (CH) secondary to subarachnoid hemorrhage. The presentation was delivered at ESMINT 2023, the 15th congress of the European Society Minimally Invasive Neurological Therapy held September 4-6 in Marseille, France.

The ETCHES I clinical trial represents the first-ever treatment with the eShunt system and the first endovascular treatment of CH, noted CereVasc.

The study was conducted under the leadership of Prof. Pedro Lylyk, a neurosurgeon and Director and CEO of ENERI (Equipo de Neurocirugía Endovascular y Radiología Intervencionista) and Clínica La Sagrada Familia in Buenos Aires, Argentina.

Ivan Lylyk, MD, one of the lead investigators at Clínica La Sagrada Familia, presented “Early Experience With the eShunt Implant in the Management of Aneurysmal Subarachnoid Hemorrhage Intractable Hydrocephalus,” which described the short-term impact of the eShunt system in patients with persistent CH and elevated intracranial pressure in lieu of an invasive surgical placement of a conventional ventriculoperitoneal shunt.

“We are excited by the initial data demonstrating the potential to provide patients a minimally invasive treatment for communicating hydrocephalus,” commented Prof. Pedro Lylyk in the company’s press release. “Transformational innovation in the management of hydrocephalus is long overdue. These results provide confidence that it may finally be on the horizon.”

Mr. Levangie stated, “We are thrilled by the results reported, and grateful to Dr. Lylyk and the team from Clinica Sagrada Familia for presenting their clinical experience with the eShunt system to the physician community. The data presented at ESMINT bolster our confidence in the potential of the company’s minimally invasive treatment of hydrocephalus as we transition to the pivotal clinical trial in early 2024.”