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Electronics


an operating room to be able to place the electronics into the body and interface with nerves in a way that ensures those electrodes don’t move over the years. Add it all up and you have costs on a ten- year timescale of $100,000–150,000 for implanted neuromodulation devices, even for conditions that don’t require 24/7 stimulation.


“‘What’s the main hold up stopping neuromodulation from gaining treatment market share?’ It’s not effi cacy, it’s not safety – it’s the perceived risk.”


Manfred Franke


Due to these large costs for the healthcare system, you have to ensure a treatment will be effective before implanting it. State of the art treatments use so-called trial leads, which are leads with electrodes that are intended to be placed via needle, anchored with adhesive dressings where they exit the body, and connected to an external signal generator. The risk of infection means that the clinician has up to seven days for some indications and up to 30 days for others to confirm that a patient is a responder for the treatment. Unfortunately, in some cases, these trial leads and their electrodes move and, in others, the waveforms that may provide treatment are simply not found out in time. As a result, we are not finding every patient that is likely to benefit from neuromodulation. We realised at Neuronoff that there must be a better way to do this, with a connector that conducts an electrical signal from right underneath the skin down to the nerve of interest. And we kept coming back to the basic principle that we needed something needle-injectable, with a needle of about 1mm in diameter, to create an electrode on the nerve that does not move after it’s put in place. This is how the Injectrode was born.


Because the Injectrode is needle- injectable and mechanically secures itself near a nerve target, it removes the need for sutures to secure it inside the body or to close up the needle puncture – and leaving the Injectrode just underneath the skin allows you to wirelessly provide a signal from the outside, with, for example, a TENS unit. So, you can use a relatively simple and versatile device, and you can figure out the best signal for a particular patient in a trial period that could now last ten years if you wanted, because you don’t have a wire crossing the skin anymore. Tens of thousands of people with chronic conditions may now be able to receive a therapy that is friendly for the patient, the physician and the payer.


The idea here really is asking,


‘What’s the main hold up stopping neuromodulation from gaining treatment market share?’ It’s


80 Medical Device Developments / www.nsmedicaldevices.com


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