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Neuro Implant Innovation

Shunt Design for Hydrocephalus.png

The Problem and Opportunity

Current shunt systems are not ideal- they create nonphysiologic drainage and have high complication and revision rates. This surgical and medical device therapeutic solution seeks to resolve many of the high-risk complications of standard ventriculoperitoneal hydrocephalous shunts.

Client

Northeastern University Bioengineering Dept.

Services

product research, sprint and solutioning, project management 

The Solution

The first part of this solution is the surgical ETV procedure, or endoscopic third ventriculostomy. In this procedure, patients with non-communicating hydrocephalus have a controlled hole created through the bottom of the occluded third ventricle, allowing CSF to at least flow properly throughout the cranium. Establishing communicating hydrocephalus creates the best case hydrocephalus and may help some fluid naturally drain away, reducing the load on the shunt. 

Combined with this procedure is a CPC, or a choroid plexus cauterization. The procedure cauterizes some of the choroid plexus (the tissue that produces CSF, and that clogs shunt inlet valves) in half of the ventricles inside the brain. This decreases the amount of fluid produced and may also reduce the strength of pulses that can cause the ventricles to enlarge. This combined ETV/CPC is superior to ETV alone and will lay the groundwork for a more minimally invasive shunt by reducing the burden of hydrocephalus production. [Boston Children’s]

Finally, a novel minimally invasive shunt that drains the CSF from the cerebral ventricles to the cerebral venous sinuses will be implanted. This shunt model has several promising studies but has not as of yet been widely adopted. *more info This mode of shunt is uniquely able to mimic physiological conditions with the added advantages of avoiding over-drainage and extracranial recipient site complications. [NCBI] Our Team has designed novel advancements to this modality which allows for patient-specific treatment and accurate adjusting based on the patient’s ICP and other factors allow for a measurement and control system.

Flow sensors at the distal end of the catheter will be used to track flow rate in real time and contribute to building out a patient portfolio and help doctors and clinicians understand the patient’s daily flow and allow insights into pulsatile flow, which emerging research is indicating may be more important that understood before. This patient data will be transmitted from the shunt device to a secure mobile and web application. The data can provide alerts to decline of shunt function. Future work will be the implementation of key Smart features that will allow the device to automatically respond to negative changes in the shunt performance and current them, with an alert sent to the patient and other designated individuals. 

These features will give the patient freedom from debilitating symptoms associated with ventriculoperitoneal shunts (intense migraines, inability to sleep on side shunt is placed, HCS symptoms),and instead offer far more frequent flow measurements- giving peace of mind to the patients and their support team, and superior management of the conditions of the disease.

Further study will be required to address several Achilles heels. First, closure of the pathway created using ETV can be sudden and life-threatening. Pathway closure occurs in 20 to 50% of patients within five years of the procedure with the great majority of treatment failures occurring within the first six months of the operation. [Hydo Association] The Team believes that there is opportunity for a bioresorbable polymer stent-like device to be placed in the surgical opening in the third ventricle to help the hole heal open.

Other areas of further investigation will be to determine the percent of patients who are candidates for the combined ETV/CPC procedure, and to specifically determine if the procedure will be successful in geriatric patients (the procedure is currently developed for pediatrics). Additionally the risks associated with the ventriculosinus surgical procedure and revision

Regulatory Process

Like most shunts in the market, our device would be classified as a Class 2 device. But seeing the high risk of the device and by the 95-5 rule, we would mostly be classified as Class 2 with Special Controls to further prove the safety and efficacy of our device. Hence just like Codman Hakim and other shunts in the market,  despite having to do 510(k) submissions, we would still be required by the FDA to undergo clinical trials.

After being classified as Class 2 with Special Controls by the FDA, we will have to submit the Device Master Files to the FDA. We will then be required to submit an Investigational Device Exemption in order to carry out clinical trials. Before submission we will request for a Pre-IDE meeting to clear out what all is required from us so that our first submission itself is approved as time is of the essence when releasing a product. After finalizing the Product Development Protocol, the start and end points of the clinical trial and the follow up period etc, we will then proceed with the IDE Submission. After this submission is approved, we will then start the clinical trials of the device. After the required time period, we will collect, analyze and study the data points of the trials and prove its feasibility to the FDA through the 510(k) Traditional Submission. Before this submission too, we would request for a meeting with the FDA to find out the deliverables needed in the final submission. This meeting will help us in submitting thorough documentation and reduce the time period to then be granted FDA Clearance. 

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