Medtronic today announced the first patient implant in a clinical study of its investigative, closed-loop, implantable neurostimulator. The ‘Evaluation of long-term patient experience with a Medtronic closed-loop SCS [spinal cord stimulation] system’ study is being conducted in Australia, and its objective is to characterise the efficacy of the company’s rechargeable neurostimulator for the treatment of overall pain in back and limb pain subjects.
Medtronic’s closed-loop feature uses the spinal cord’s physiological response to stimulation, known as an evoked compound action potential (ECAP), to automatically deliver a consistent therapeutic dose at the precise moment it is needed, according to a press release. ECAPs are signals generated by the spinal cord in response to an electrical stimulus. They are a direct measure of how many nerve fibres are activated in the spinal cord and provide a metric that can be used to inform real-time, patient-specific control of SCS therapy.
“As SCS patients go about their daily lives, their dosage needs vary,” said Vahid Mohabbati (Sydney Pain Research Centre, Sydney, Australia), the first physician to implant a patient with the investigational device for the study. “Maintaining the right intensity of stimulation is essential for treating patients with SCS. It is our hope that the closed-loop feature will enable more personalised and real-time stimulation adjustments that reduce pain while minimising variances that fall outside of the optimal therapeutic dose.”
Enrolling up to 90 patients across 10 centres in Australia, this prospective, multicentre, randomised, investigational feasibility study will evaluate the long-term performance of the closed-loop algorithm and overall patient experience with the study device, Medtronic states. Following device implantation and optimisation, subjects will be randomised to a sequence of ‘closed-loop on’ and ‘closed-loop off’ for in-clinic testing. They will then continue being followed for a total study duration of up to 24 months.
“This study serves as another example of Medtronic’s continued commitment to ensuring that chronic pain patients receive the best possible care through clinically validated treatment options,” said Charlie Covert, vice president and general manager of Pain Therapies at Medtronic. “Closed-loop technology represents a tremendous opportunity to create a more personalised therapy that offers durable, consistent and effective pain relief.”
The next-generation, closed-loop neurostimulator is investigational in Australia, and has not been approved for sale or distribution, the press release details. Medtronic also notes that this study is independent of its submission to the US Food and Drug Administration (FDA) for approval of its closed-loop rechargeable neurostimulator—a device that is not approved or cleared in the USA for commercial use.