CereVasc announced today that it received FDA breakthrough device designation for its investigational eShunt system. The breakthrough nod marks Boston-based CereVasc’s second for eShunt. It covers the treatment of communicating hydrocephalus in pediatric patients aged 12 and older. eShunt received its initial FDA breakthrough device designation last August. Last May, the company received the FDA’s […]
cerevasc
CereVasc randomizes first patient in head-to-head study of eShunt, standard of care
CereVasc today announced the first patient randomized to and treated with the eShunt system in its STRIDE clinical trial. STRIDE, a head-to-head comparison, pits the novel eShunt system against the standard of care ventriculo-peritoneal (VP) shunt in patients with normal pressure hydrocephalus (NPH). Investigators treated the first patient at VCU Health in Richmond. The study […]
CereVasc study data backs eShunt system
CereVasc today announced initial results from a pilot clinical study supporting the use of its eShunt system. Boston-based CereVasc designed eShunt for treating normal pressure hydrocephalus (NPH). This study evaluates the technology in the treatment of elderly patients with NPH. eShunt has FDA breakthrough device designation, which it picked up last August. eShunt offers a […]
CereVasc wins FDA breakthrough nod for eShunt system
CereVasc announced today that it received FDA breakthrough device designation for its eShunt system for treating normal pressure hydrocephalus (NPH). The company said data generated during pilot clinical studies of the device supported the breakthrough device designation. This designation enables priority review and enhanced communication with the FDA during the clinical trial and premarket review […]
CereVasc raises $70M Series B to support eShunt
CereVasc announced today that it completed the initial closing of its Series B funding round worth $70 million. Bain Capital Life Sciences and existing investor Perceptive Xontogeny Venture Fund (PXV) jointly led the financing. Other existing investors also participated. The Boston-based company plans to use the funds to support the clinical and regulatory development of […]
CereVasc can begin new IDE study of eShunt
CereVasc announced today that it received FDA investigational device exemption (IDE) approval to begin a pivotal study of its eShunt. The FDA said the Boston-based company can initiate the STRIDE pivotal study looking at eShunt in treating normal pressure hydrocephalus. IDE approval allows the company look at the novel system’s safety and efficacy. The study […]
CereVasc wins FDA IDE to expand eShunt trial
CereVasc announced today that the FDA approved an investigational device exemption (IDE) supplement for a study of its eShunt system. The FDA permitted the expansion of the study for patients with normal pressure hydrocephalus (NPH) to additional participants and sites. The company initiated the pilot study of its eShunt system under IDE in August 2022. […]
CereVasc, LianMedical announce corporate partnership
CereVasc today announced a partnership with LianMedical to bring CereVasc’s technology to Asia. The partnership aims to accelerate the introduction of breakthrough medical technologies to markets in China, Hong Kong, Taiwan and Macaw. The partnership will focus on bringing CereVasc’s eShunt system and related products to the region. “We are very excited by the opportunity […]
Cerevasc has a new chief medical officer
CereVasc announced today that it appointed Dr. Adel Malek as its new chief medical officer (CMO). The Boston-based neurological disease treatment company develops the eShunt system for treating communicating hydrocephalus. In a news release, it said Malek’s appointment can help further accelerate the development and clinical strategy for eShunt. Current treatment for hydrocephalus requires an […]
CereVasc completes first eShunt procedure in U.S.
CereVasc announced today that it completed the first procedure with its 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 […]
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 […]
