an improved hydrocephalus shunt
CSF-Dynamics is developing a new type of hydrocephalus shunt that overcomes the major issues of current shunts on the market. The shunt is currently undergoing clinical testing. CSF-Dynamics expects the shunt to be approved for clinical use by end of 2025.
CSF-Dynamics received a Horizon 2020 Phase 2 SME grant (849502) from the European Commission to support our First in Human trial. We are now planning a larger Pivotal Study.
Please contact us by email if you are interested to know more about the technology and the status of the development.
We are proud to announce that the preliminary results of the First-in-Human clinical study will be presented at annual meeting of Scandinavian Neurosurgical Society (SNS) by Sune Munthe MD, PhD, neurosugeon, Odense University Hospital, Denmark, on Sunday 15 May 2022 at 2:10 pm, session A123, Radisson Blu, Bergen, Norway.
Svend Erik Børgesen, MD (Chief Clinical Officer, CSF-Dynamics) will be present at the session to answer any questions. Please feel free to contact us. See contact details by clicking the button.
The first preliminary results of the First-in-Human clinical study was presented at AANS by Mikkel Andersen MD, Odense University Hospital, Denmark, 2 May 2022 at AANS, Pennsylvania Convention Center.
Present day shunts cannot deliver normal physiological flow
Since the invention and introduction of cerebral shunts in the 1950s, the two most important innovations have been the addition of an anti-gravitational valve plus a feature to adjust the valve setting magnetically. Despite these innovations the clinical outcome has not improved in any significant way, and shunts continue to have an unacceptable tendency to malfunction with revisions still commonplace (30% within 6 months). Moreover, shunts fail to provide normal and controlled drainage of CSF because the drainage profile of a shunt is very different from physiological drainage. With current shunts, too much or too little CSF can be drained depending on factors such as body position or the inconstant pressure within the absorption site (heart or abdomen). This lack of synchronisation can result in large variations in intracranial pressure preventing the patient from leading a normal life.
SinuShunt: Following the principle of physiological drainage
The SinuShunt mimics normal physiological absorption of CSF by draining into the intracranial sinus vein. There are three important advantages: (i) the differential pressure variation between the ventricles and the absorption site is minimised, (ii) the detrimental siphon effect is eliminated, and (iii) the unfavourable peritoneal cavity is avoided as a drainage site. The SinuShunt can therefore operate independently of any arbitrary physical forces which can affect standard VP (as well as VA) shunts.
Shunting to the sinus vein is an obvious solution since it mimics normal CSF drainage. Different researchers have recognised this and have tested the concept over recent decades, but all concluded that despite the patient experiencing clinical benefit, a shunt outlet could not last in the intracranial sinus vein, and that it would eventually become enveloped in endothelium, usually within 3 months.
Based on our own comprehensive clinical experiences with the first generation SinuShunt (tested on 110 patients), we have now developed a new generation of the device to overcome this technical shortfall of the outlet becoming overgrown. The new SinuShunt is designed to keep the outlet in the middle of the vein, preventing contact with the wall of the vein and ensuring the CSF flows unhindered.
First-in-Human and pivotal clinical studies
Odense University Hospital in Denmark has been conducting the First in Human clinical study with 12 patients (2020-2022), led by neurosurgeon Dr Sune Munthe. The purpose of the study has been to demonstrate that the SinuShunt outlet will stay patent for at least 6 months. The study will conclude in August 2022 with no failures reported as of April 2022.
Based on these very positive results we are currently preparing the pivotal study (86 patients) which will be conducted across at least 4 clinical sites in four countries. This study will provide the necessary data for future FDA approval (US market) and CE marking (European market).
CSF-Dynamics was founded in 1996 by Svend Erik Børgesen, Dr. Med. Sci., former chief neurosurgeon at the Danish National Hospital in Copenhagen, specialist in hydrocephalus, recipient of the Medtronic Pudenz Prize and recognised by the Queen of Denmark for neurosurgical services. After operating more than 500 hydrocephalus patients (as well as many other operations), he invented the SinuShunt™ as a response to the need for a radically better hydrocephalus shunt which would continue to work on a long-term basis.
Initial results from his research conducted 2001-2003 showed that shunting to the intracranial venous sinus reduced overdrainage and demonstrated clinical benefit but would require additional design changes to prevent endothelium overgrowth of the outlet. Post-retirement, Dr Børgesen partnered with the Danish engineering consultancy 2C ENGINEERING in 2017 to redesign the outlet, leading to the First in Human Trial from 2020 onwards. So far, data collected is extremely promising with the outlet remaining open for over 6 months indicating better-than-average shunt survival and confirming that shunting to the intercranial venous sinus provides a safe, simple and long-lasting solution.