Periodic Reporting for period 2 - PercPad (THE FIRST PERCUTANEOUSLY IMPLANTABLE PADDLE LEAD FOR SPINAL CORD STIMULATION)
Período documentado: 2021-09-01 hasta 2022-08-31
In today’s society, 3 in every 5 adults attending primary healthcare facilities do so because they suffer chronic pain. This demand surpasses the visits registered together for cancer, diabetes and cardiovascular diseases, putting all players of the healthcare system under an unnerving pressure. Because of its economic impact (around €300 Billion/year in the EU only) chronic pain is considered one of the healthcare priorities worldwide.
Spinal Cord Stimulation (SCS) is the most effective drug-free way to treat chronic pain. However, the SCS solutions currently available either require expensive, complex and invasive surgeries, or feature limited reliability and low effectiveness.
SCS is applied by means of implanting an implantable pulse generator (IPG) and placing a set of electrodes (leads) into the epidural space. The leads currently available on the market are of two kinds: Multicolumn Paddle Leads, that are inserted via an invasive surgical procedure, and Cylindrical Leads, that can be implanted percutaneously. Neither option represents the ideal lead, with either holding several pitfalls:
• Multicolumn Paddle Leads allow very effective, directional and spatially controlled stimulation, but their placing requires expensive and invasive surgery, and their removal is very complicated.
• Percutaneous Cylindrical Leads can be implanted through a needle with a minimally invasive surgery and can be removed more easily than the paddles, however:
o they do not allow directional stimulation, causing stimulation-evoked discomfort to patients and higher battery consumption, with possible need to replace the IPG.
o they do not allow spatially controlled stimulation, resulting in less effective treatment.
o they show higher lead migration or displacement rates, causing higher reoperation rates in the medium and in the long term to replace the damaged or ineffective devices.
The challenge is to give both practitioners and patients a new generation of SCS leads, that combine the best features of today's available products. The production of a lead with these features is possible only with our patented SCBI technology allowing to produce leads that are extremely thin, flexible and stretchable. The PercPad project will provide an entirely new type of implantable leads, the SCS Heron LeadTM: the first SCS multicolumn paddle lead for chronic pain therapy that can be implanted percutaneously.
Spinal Cord Stimulation (SCS) is the most effective drug-free way to treat chronic pain. However, the SCS solutions currently available either require expensive, complex and invasive surgeries, or feature limited reliability and low effectiveness.
SCS is applied by means of implanting an implantable pulse generator (IPG) and placing a set of electrodes (leads) into the epidural space. The leads currently available on the market are of two kinds: Multicolumn Paddle Leads, that are inserted via an invasive surgical procedure, and Cylindrical Leads, that can be implanted percutaneously. Neither option represents the ideal lead, with either holding several pitfalls:
• Multicolumn Paddle Leads allow very effective, directional and spatially controlled stimulation, but their placing requires expensive and invasive surgery, and their removal is very complicated.
• Percutaneous Cylindrical Leads can be implanted through a needle with a minimally invasive surgery and can be removed more easily than the paddles, however:
o they do not allow directional stimulation, causing stimulation-evoked discomfort to patients and higher battery consumption, with possible need to replace the IPG.
o they do not allow spatially controlled stimulation, resulting in less effective treatment.
o they show higher lead migration or displacement rates, causing higher reoperation rates in the medium and in the long term to replace the damaged or ineffective devices.
The challenge is to give both practitioners and patients a new generation of SCS leads, that combine the best features of today's available products. The production of a lead with these features is possible only with our patented SCBI technology allowing to produce leads that are extremely thin, flexible and stretchable. The PercPad project will provide an entirely new type of implantable leads, the SCS Heron LeadTM: the first SCS multicolumn paddle lead for chronic pain therapy that can be implanted percutaneously.
Four usability studies have been performed to gather high-level usability requirements from neurosurgeons and pain specialists.
The three main activities conducted so far are:
1. the definition of the device risk management plan;
2. the identification of potential hazards and adverse events known from similar devices;
A list of product requirements (design inputs) was defined. The requirements have been generated by possible risks mitigation, input from the user interactions and engineering analysis.
The design of the Heron lead (the paddle lead) has been optimized to match all the mechanical, physical and electrical requirements.
Multiple solutions have been generated for each macro element and the selection of the best solution was always conducted against multiple ranking criteria like but not limited to:
• Biocompatibility
• Compatibility with the introducer
• Safety for the patient
• Easiness of fabrication
• Robustness
• Availability
• Price
Final cleaning, packaging, labelling and sterilization processes have been designed and implemented to assure full compliance to FDA and EU standards. The processes have been designed to meet the specific ISO and FDA requirements.
Testing was performed with the WISE Heron Lead to support substantial equivalence to the predicate devices. Testing included performance testing, biocompatibility, and shelf-life testing.
Bench testing was conducted on WISE Heron Lead devices that were exposed to sterilization, accelerated aging, environmental conditioning and transport simulation prior to testing. In addition, to ensure their integrity even under conditions of misuse, functional and performance tests were conducted after the devices were exposed to life conditioning, i.e. cable flex, connector flex, tensile force, multiple insertion in the introduction system, multiple insertion in the IPG.
Biocompatibility testing was also conducted to demonstrate the safety, suitability and biocompatibility of the WISE Heron Lead final finished device.
The usability and animal studies performed the study gave as feedback that the surgical procedure by laminectomy was safe and effective for implanting a Heron Lead in the epidural space and comparable, in terms of difficulty and duration of the implantation, with the actual implantation procedures.
Manufacturing processes have been developed to be ready for high-volume production and The production processes have been validated in order to guarantee the quality of the product and its conformity to the production Equivalent specifications.
The three main activities conducted so far are:
1. the definition of the device risk management plan;
2. the identification of potential hazards and adverse events known from similar devices;
A list of product requirements (design inputs) was defined. The requirements have been generated by possible risks mitigation, input from the user interactions and engineering analysis.
The design of the Heron lead (the paddle lead) has been optimized to match all the mechanical, physical and electrical requirements.
Multiple solutions have been generated for each macro element and the selection of the best solution was always conducted against multiple ranking criteria like but not limited to:
• Biocompatibility
• Compatibility with the introducer
• Safety for the patient
• Easiness of fabrication
• Robustness
• Availability
• Price
Final cleaning, packaging, labelling and sterilization processes have been designed and implemented to assure full compliance to FDA and EU standards. The processes have been designed to meet the specific ISO and FDA requirements.
Testing was performed with the WISE Heron Lead to support substantial equivalence to the predicate devices. Testing included performance testing, biocompatibility, and shelf-life testing.
Bench testing was conducted on WISE Heron Lead devices that were exposed to sterilization, accelerated aging, environmental conditioning and transport simulation prior to testing. In addition, to ensure their integrity even under conditions of misuse, functional and performance tests were conducted after the devices were exposed to life conditioning, i.e. cable flex, connector flex, tensile force, multiple insertion in the introduction system, multiple insertion in the IPG.
Biocompatibility testing was also conducted to demonstrate the safety, suitability and biocompatibility of the WISE Heron Lead final finished device.
The usability and animal studies performed the study gave as feedback that the surgical procedure by laminectomy was safe and effective for implanting a Heron Lead in the epidural space and comparable, in terms of difficulty and duration of the implantation, with the actual implantation procedures.
Manufacturing processes have been developed to be ready for high-volume production and The production processes have been validated in order to guarantee the quality of the product and its conformity to the production Equivalent specifications.
Our prototype demonstrated for the first time, to our knowledge, its capability to insert a multicolumn paddle lead percutaneously via a mini-invasive procedure. The prototype consists of a multicolumn paddle lead folded in a catheter that can be pushed in the subdural space of the spinal cord and deployed at the therapeutical site. In the final configuration of the product the leads have been tested in its final configuration and the full mini-invasive procedure have been demonstrated. This allow for the first time, to achieve a minimally invasive implantation of this type of electrodes, which will allow to reach overall savings of up to €140,000 per patient by avoiding a complex and invasive surgery.
- the projections of the growth of the Neuromodulation Market indicated in the DoA did not consider the impact of the COVID pandemic, that at the time of the application could not be estimated by anyone. Indeed, during 2020 and 2021 the Neuromodulation market did not experience the forecasted growth due to the global COVID crisis that strongly reduced all the medical practices. Nevertheless, recent peer-to-peer interviews with the market players indicate that starting from 2022 the Neuromodulation market regained traction, substantially recovering the 2019 market size and expected future CAGR.
- because of a different approach requested by the FDA, an additional step in the procedure for the submission of to the FDA was required. Although this step was executed on 2 August, it is not possible to predict how long the interaction with the FDA will take for the obtainment of their agreement. For this reason, the plan of commercialization starting from Q4 2022 has to be shifted accordingly. Nevertheless, the 3-steps commercialization strategy described in the DoA remain unchanged, only rigidly shifted. The “Changes on specific country market regulations” was indeed accounted in the DoA as a potential Commercial Risk having a moderate probability and moderate impact on the project.
Concerning the growth of the company workforce for meeting the industrial and commercial requirements of the project (Figure 24 of the DoA), the company actually exceeded its forecast, as by end of 2022 the company will include 36 operatives instead of the 27 initially forecasted.
- the projections of the growth of the Neuromodulation Market indicated in the DoA did not consider the impact of the COVID pandemic, that at the time of the application could not be estimated by anyone. Indeed, during 2020 and 2021 the Neuromodulation market did not experience the forecasted growth due to the global COVID crisis that strongly reduced all the medical practices. Nevertheless, recent peer-to-peer interviews with the market players indicate that starting from 2022 the Neuromodulation market regained traction, substantially recovering the 2019 market size and expected future CAGR.
- because of a different approach requested by the FDA, an additional step in the procedure for the submission of to the FDA was required. Although this step was executed on 2 August, it is not possible to predict how long the interaction with the FDA will take for the obtainment of their agreement. For this reason, the plan of commercialization starting from Q4 2022 has to be shifted accordingly. Nevertheless, the 3-steps commercialization strategy described in the DoA remain unchanged, only rigidly shifted. The “Changes on specific country market regulations” was indeed accounted in the DoA as a potential Commercial Risk having a moderate probability and moderate impact on the project.
Concerning the growth of the company workforce for meeting the industrial and commercial requirements of the project (Figure 24 of the DoA), the company actually exceeded its forecast, as by end of 2022 the company will include 36 operatives instead of the 27 initially forecasted.