Pleural Dynamics today announced positive results from a prospective, multicenter study evaluating its ACES (automatic continuous effusion shunt) device. Plymouth, Minnesota-based Pleural Dynamics developed ACES to treat chronic pleural effusions. It describes it as the first and only fully implantable automatic effusion shunt that uses the motion … [Read more...] about Pleural Dynamics reports positive data for automatic effusion shunt
Shunts
Pleural Dynamics earns Medicare win for effusion shunt
Pleural Dynamics announced today that it received a new CMS code for its ACES (automatic continuous effusion shunt) device. CMS issued a new Healthcare Common Procedure Coding System (HCPCS) code and New Technology Ambulatory Payment Classification (NTAPC) assignment for ACES, a device designed to treat chronic pleural effusions. The new code, … [Read more...] about Pleural Dynamics earns Medicare win for effusion shunt
Pleural Dynamics completes enrollment in shunt study
Pleural Dynamics announced today that it completed enrollment in a post-market clinical study for its ACES system. Minneapolis-based Pleural Dynamics designed the ACES (automatic continuous effusion shunt) system as the first and only fully implantable automatic effusion shunt that uses the motion of normal breathing to remove fluid from the … [Read more...] about Pleural Dynamics completes enrollment in shunt study
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
