Medtronic's Inceptiv Closed-Loop Spinal Cord Stimulator Demonstrates Significant Reduction in Over-Stimulation and Minimal Patient Adjustments in Pivotal Clinical Study

Jan 26, 2025 22:15 CST Updated 22:15

Medtronic

Medical Device Manufacturer

Medtronic Unveils Its Closed-Loop Rechargeable Spinal Cord Stimulator at NANS 2025---InceptivClinical research data. The study showsInceptivExcellent long-term efficacy.

This study is a prospective, multi-center, single-arm clinical study, evaluatingInceptivLong-term efficacy in treating chronic neuropathic pain. Patients were randomly divided into closed-loop on/off groups.

Study Specific Data(12 months post-operation)

93% of patients reported a reduction in CL feature overstimulation during clinical testing (n=43).
88% of patients prefer CL function to be turned on (compared to off; n=43)
Home Experience Consistent with Clinical Test Results --- 91% of Participants (n=46) Reported No Uncomfortable Stimulation During Daily Life Activities
82% of people reported a reduction in low back pain intensity of 50% or more, with an average reduction of 67% (n=38).
50% of patients were able to reduce or discontinue opioid use (n=32, baseline MME>0).
87% of subjects (n=46) showed improvement in three or more domains of the composite endpoint, including pain (VAS score reduction ≥30%), quality of life (EQ-5D-5L score increase ≥0.074), physical function (Oswestry Disability Index reduction ≥10), mood (POMS score decrease ≥10), and sleep quality (PSQI score decrease ≥3.0).
With the closed-loop function enabled, patients make only one median adjustment to the programming every 30 days. In contrast, in a U.S. market research survey of spinal cord stimulation patients across multiple manufacturers, 50% of participants (n=100) made frequent adjustments at least several times per week.
100% of the subjects (n=46) were satisfied with CL-SCS treatment, and 98% would recommend it to friends and family.

PI Evaluation

"Data over 12 months show that Inceptiv with closed-loop technology offers significant benefits in improving pain, quality of life, and physical function scores while substantially reducing overstimulation. Fifty percent of patients were able to reduce or stop the use of opioid pain medications, and the median number of adjustments to stimulation amplitude by patients was only once every 30 days. This finding highlights that Inceptiv with closed-loop sensing can reduce treatment burden while providing effective pain relief. These results underscore the importance of customized stimulation and ensuring dose consistency so that patients can achieve optimal benefits from spinal cord stimulation therapy during their daily living activities."

---Vahid Mohabati Sydney Pain Research Centre

Executive Evaluation

"These results add to the growing body of high-quality evidence demonstrating the long-term efficacy of SCS in reducing pain and improving quality of life. We are particularly pleased that many patients in this study not only found pain relief with Inceptiv SCS but also benefited from its closed-loop functionality, which automatically adjusts stimulation, reducing the burden of manual adjustments. The decreased need for manual adjustments, combined with positive treatment experiences and satisfaction, may lead to better treatment adherence and sustained outcomes."

---Ashwini Sharan MedtronicChief Medical Officer of Neuromodulation

Inceptiv

InceptivWhich adopts the ECAP (Evoked Compound Action Potential) closed-loop functionSpinal Cord Stimulator, this is the result of Medtronic's decades of research and development, unlocking the ability to listen and respond to signals along the spinal cord. ECAP directly measures the degree to which neural tissue in the spinal cord is activated in response to electrical stimulation, providing real-time information that allows the system to respond to the patient's movement. In a clinical study, compared with fixed-output stimulation,Open-loopSpinal Cord StimulatorIn comparison, 90% of patients prefer the optional choice.Inceptiv。

InceptivSenses the body's response to stimulation 50 times per second† and immediately increases or decreases the stimulation to maintain the prescribed settings determined by the doctor.

InceptivIs the thinnest in the worldSpinal Cord Stimulator with a thickness of only 6mm, and it can also be used without charging, requiring only 1It can be fully charged from a completely empty state in just hours, making it very convenient and fast.

InceptivIt is still the only spinal cord stimulator that allows full-body 1.5T and 3T MRI scans, enabling patients to undergo MRI examinations. This is because MRI detection is essential after implantation.Spinal cord stimulator patients must, according to Medtronic statisticsUp to 84%The patient after implantationSpinal cord stimulators need to undergo MRI examinations within five years.

Differences in Spinal Cord Stimulators Among Global Leading CompaniesInceptivPerformance surpasses othersSpinal Cord StimulationStimulator.

Inceptiv Demonstration

Medtronic

Medtronic is one of the largest medical technology, services, and solutions companies in the world, alleviating pain, restoring health, and extending life for millions of people globally. With over 90,000 employees worldwide, Medtronic serves doctors, hospitals, and patients in more than 150 countries. The company is committed to collaborating with stakeholders around the world to advance healthcare.