Periodic Reporting for period 2 - SINUSHUNT (SinuShunt – New disruptive medical device for treatment of hydrocephalus)
Reporting period: 2020-02-01 to 2021-09-30
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 only solution for the majority of cases 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 needs to be removed and replaced. 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.
The overall objectives of this project are to bring the SinuShunt closer to market. The project has validated the functionality and durability of our device as a long-lasting solution for the treatment of hydrocephalus. Achievements include:
• Fine tuning of the shunt to ensure optimal functionality and manufacturability
• Establishing manufacturing in regulated environments and produce and test products for studies
• Testing robustness of outlet through the Venous Access Port
Shunting devices remain the only solution for the majority of cases 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 needs to be removed and replaced. 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.
The overall objectives of this project are to bring the SinuShunt closer to market. The project has validated the functionality and durability of our device as a long-lasting solution for the treatment of hydrocephalus. Achievements include:
• Fine tuning of the shunt to ensure optimal functionality and manufacturability
• Establishing manufacturing in regulated environments and produce and test products for studies
• Testing robustness of outlet through the Venous Access Port
In Period 1 our device was fine-tuned, manufactured, the components assembled and our Venous Access Port device made ready for the Proof of Concept Study.
In tandem the Design History File was developed, biocompatibility was evaluated, applications were submitted to the Competent Authority and Ethics Committee for permission to perform our clinical trial, devices were tested and sterilisation validation was completed.
In Period 2 approval from EC and CA to start the clinical trial received in February 2020
The first patient was operated in September 2020 (a delay of 6 months caused by moving of the neurosurgical dept, plus COVID-19).
The second site (Odense) joined the trial in September 2020.
13 patients operated in total, 2 more scheduled for November 2021.
FDA Breakthrough Designation application submitted
Japanese patent granted.
Chinese patent granted
Since the study is not quite yet complete exploitation and dissemination have not yet started but are planned for May 2022 onwards to coincide with the study results.
In tandem the Design History File was developed, biocompatibility was evaluated, applications were submitted to the Competent Authority and Ethics Committee for permission to perform our clinical trial, devices were tested and sterilisation validation was completed.
In Period 2 approval from EC and CA to start the clinical trial received in February 2020
The first patient was operated in September 2020 (a delay of 6 months caused by moving of the neurosurgical dept, plus COVID-19).
The second site (Odense) joined the trial in September 2020.
13 patients operated in total, 2 more scheduled for November 2021.
FDA Breakthrough Designation application submitted
Japanese patent granted.
Chinese patent granted
Since the study is not quite yet complete exploitation and dissemination have not yet started but are planned for May 2022 onwards to coincide with the study results.
With 13 patients now operated in our Proof of Concept study, and no symptoms of overdrainage we are planning for our larger pivotal study on 82 patients.
Preventing shunt failure has a major socio-economic impact since at least half of the 200,000 annual shunt operations in the world are operations to replace shunts which have stopped working. 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 a lifetime.
Preventing shunt failure has a major socio-economic impact since at least half of the 200,000 annual shunt operations in the world are operations to replace shunts which have stopped working. 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 a lifetime.