CereVasc announced today that it completed patient enrollment in the STRIDE pivotal trial evaluating its investigational eShunt system. Boston-based CereVasc said it completed enrollment at 32 clinical sites. Now, STRIDE continues to progress through remaining treatment and follow-up activities for consented patients. The company said it is on … [Read more...] about CereVasc completes enrollment in eShunt trial
CereVasc
CereVasc reports first-in-human use of eShunt for idiopathic intracranial hypertension
CereVasc today announced the first-in-human case report for the use of its eShunt system to treat medically refractory idiopathic intracranial hypertension (IIH). IIH, formerly known as pseudotumor cerebri, is characterized by elevated pressure around the brain without an identifiable structural cause. The condition is associated with chronic … [Read more...] about CereVasc reports first-in-human use of eShunt for idiopathic intracranial hypertension
CereVasc has ‘encouraging’ eShunt data
CereVasc says a new study showed 95% of participants clinically improved through 90 days of follow-up with the company’s eShunt System. The prospective, multi-center, single-arm clinical study, published in the Journal of NeuroInterventional Surgery (JNIS), involved 66 people with normal pressure hydrocephalus (NPH) treated at 12 sites in the … [Read more...] about CereVasc has ‘encouraging’ eShunt data
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 … [Read more...] about CereVasc randomizes first patient in head-to-head study of eShunt, standard of care
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 … [Read more...] about CereVasc study data backs eShunt system
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 … [Read more...] about CereVasc wins FDA breakthrough nod for eShunt system
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 … [Read more...] about Cerevasc raises $70M Series B to support eShunt
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 … [Read more...] about CereVasc can begin new IDE study of eShunt
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 … [Read more...] about CereVasc wins FDA IDE to expand eShunt trial
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 … [Read more...] about CereVasc wins FDA IDE approval to begin eShunt pilot study
