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SinuShunt – New disruptive medical device for treatment of hydrocephalus

Periodic Reporting for period 1 - SINUSHUNT (SinuShunt – New disruptive medical device for treatment of hydrocephalus)

Reporting period: 2019-02-01 to 2020-01-31

Hydrocephalus is a devastating neurological condition caused by accumulation of cerebrospinal fluid (CSF) in the ventricles of the brain and, if left untreated, it can be fatal. There is an increasing awareness of the disease with the number of incidences relatively high (1:1000 cases in infants and 1:100 in patients over the age of 65) and the only treatment option is surgical, either by implantation of a shunting device which releases the build-up of fluid mechanically or, in some cases, by use of an endoscope going through the brain substance to its central part.
Shunting devices remain the most common solution but despite their commonality, they are based on unreliable technology from the 1950s which is known to fail every 4-8 years, due to blockage of the shunt mechanism caused by over-drainage or blockage of the shunt outlet (i.e. the end of the shunt drain) caused by clogging. In fact, 30% of the shunt failures occur in the first three months following implantation. Shunt failure results in 100,000 re-operations annually where the patient’s shunt is replaced in the hope that the similar replacement shunt will last longer. Since the procedure is highly invasive and re-operations cost health care systems €1.5 billion annually, there is a long overdue need for a sustainable solution.

CSF-Dynamics is developing a novel disruptive device which will provide lasting treatment for the condition of hydrocephalus by overcoming the issue of both over-drainage and blocked outlets.
The main innovation is to mimic the normal drainage of the cerebrospinal fluid into sinus vein which is the natural resorption place of CSF, instead of draining to the heart or abdomen which is the typical location for a hydrocephalus shunt outlet. Draining to the sinus vein will avoid the siphoning effect caused by having the drain outlet located at a distance from the usual re-absorption site (the peritoneal cavity) and will help prevent over-drainage which often causes blockage of the shunt mechanism. The second innovation is the use of stent-like technology at the outlet of the drain to avoid obstruction which often occurs through endothelial wrapping (when the end of the silicone tubing becomes embedded in its environment, e.g. the abdomen).

The overall objectives of this project are to bring the SinuShunt to market through two clinical studies to validate the functionality and durability of our device as a long-lasting solution for the treatment of hydrocephalus. This will include:
• Fine tuning of the shunt to ensure optimal functionality and manufacturability
• Establishing manufacturing in regulated environments and produce and test products for studies
• Test robustness of outlet through the venous access port
Fine tuning: we have redesigned one of our three components, the Resistance Tube which is critical to the functionality of the device. We had to design a new manufacturing process to ensure the item could be produced consistently. Prototypes were produced and the process was approved in August 2019.

Manufacturing: production and assembly of our 3 components was completed by Thursday 12 September 2019 in regulated environments. The nitinol frames were produced in Germany, the PEEK Resistance Tubes were produced in Denmark and the standard silicone tube was supplied from Germany. 200 devices were then assembled in Scotland, a sufficient number for both the initial study and the trial which will follow.

Testing: A cadaver test was performed with a prototype device in June, to ensure easy insertion and removal of the device. Mechanical tests have also been successfully performed on sterilised devices to ensure that sterilisation does not affect the performance of the device. The first clinical study of 15 patients is due to commence in March 2020.

European and US patents: the EU patent for our device was granted in January 2019 and the US patent was granted in January 2020.
We have successfully produced a device which our tests show has the capability to drain cerebral spinal fluid (CSF) from a hydrocephalus shunting device to the sagittal sinus vein in the back of the head, the natural resorption site of CSF. Our next step is to test these devices in 15 patients suffering from hydrocephalus. Once we have seen positive tests from our Proof of Concept study, we will continue to the larger multi-centre trial on 70 patients which is also part of this Horizon 2020 project.

The ability to drain to the sagittal sinus, instead of the abdomen or heart, and avoid clogging or over-growing, will be a major breakthrough for hydrocephalus patients. Over-drainage is not just one of the causes of shunt failure and re-operations, but it is also an extremely unpleasant condition which shunt patients often suffer from, significantly lowering their quality of life due to constant headaches, dizziness, and gait disturbances. Living with over-drainage is miserable, so the opportunity to have a shunting device which is not prone to these side-effects will be life changing . The end of the shunt outlet is also a breakthrough solution, designed to keep the central part of the outlet away from the walls of the vein to prevent clogging, the second most likely cause of shunt failure. Preventing shunt failure has a major socio-economic impact since at least half of the 200,000 annual shunt operations in the world are shunt replacements. Minimising shunt replacements will save health services an estimated €20,000 per patient on unnecessary brain surgeries and improve patients’ lives by having a shunt which lasts and having a shunt which does not over-drain.