Chronic Disease Medical Device and Therapy Developer
Source: Siyu MedTech; Editor: Liu XinyiReprint Requirements: Please indicate the source of the article at the beginning of the text, and it can be reprinted directly.
On January 18, 2024, Medtronic (NYSE: MDT) announced positive data from two clinical trials related to spinal cord stimulation technology.These data were shared by Medtronic at the Annual Meeting of the North American Neuromodulation Society (NANS) held in Las Vegas (January 18-21, 2024), indicating that Medtronic'sClosed-loop spinal cord stimulation technology offers benefits for treating chronic lower back pain (CLBP) and leg pain.. In addition, Medtronic also highlighted the recently FDA-approved rechargeable brain pacemaker Percept™ RC at the annual meeting. # What is Spinal Cord Stimulation?Spinal Cord Stimulation (SCS) refers to the placement of stimulating electrodes into the epidural space of the vertebral canal, which blocks pain signals by electrically stimulating the sensory neurons in the dorsal horn and the posterior tracts of the spinal cord, serving as a neuromodulation method for pain treatment. In addition, the stimulating electrodes are connected to an implantable pulse generator (IPG) via extension leads, allowing the pulse generator to be programmed using external devices.
In terms of technology,“Closed Loop”Is becoming the keyword for SCS development. In the past, SCS was implanted in an open-loop manner, meaning stimulation parameters were generally not adjusted based on changes in electrode position during a patient’s daily activities, which could easily lead to overstimulation or insufficient stimulation. Now, the evoked compound action potential (ECAP) provides a closed-loop approach for SCS, allowing for automatic and real-time objective measurement of spinal cord activation and parameter adjustments according to various postures and physical functional changes in patients.Currently, companies using closed-loop modulation include Saluda Medical, Medtronic (MDT), Abbott (ABT), Boston Scientific (BSX), Aleva Neurotherapeutics, Newronika, LivaNova, Nevro (NVRO), Biotronik, Ceregate, and Wavegate, among others. # Closed-loop SCS Research DataThis prospective study is being conducted at seven sites in Australia and is divided into two parts: a clinical test with primary endpoint assessment within one month using a randomized, crossover, single-blind design, and long-term follow-up (at 3, 6, 12, 18, and 24 months after device activation) utilizing a single-arm study design.The closed-loop SCS research data displayed by Medtronic are the results after conducting trials in Australia for 1 month and 3 months. ThisThe study evaluates the long-term use of Medtronic's next-generation closed-loop rechargeable spinal cord stimulator, which is currently under research.(Inceptiv™, which has been approved in Europe and Japan but not authorized for sale or distribution in the United States and Australia), regarding its therapeutic effects and patient experience.
Inceptiv™ closed-loop rechargeable spinal cord stimulatorThe results are as follows:
The study achieved its primary goal, with 89% of subjects reporting that compared to the open-loop SCS system,Significantly reduced incidence of overstimulation(n=28; p<0.001). In addition, 86% of subjects reported a preference for the closed-loop SCS system during the one-month blinded trial period.
The study met the secondary endpoint, with 86% of subjects (n=51) indicatingOverall, back and leg pain was reduced by 50% or more after three months.。
Three months later, 100% of the subjects expressed satisfaction with the closed-loop SCS treatment;
Three months later, more than 80% of the subjects who received SCS treatment said they were not worried about pain or side effects of the treatment and could achieve their self-defined daily activity goals.
Three months later, the group receiving closed-loop SCS showed clinically significant improvements in pain, physical function, and quality of life.
The trial did not include a withdrawal plan, however35% of subjects (n=37) who initially took opioid medications reduced/stopped use after three months.The milligram equivalent of morphine decreased from 73.5 to 54.0.
"Will closed-loop SCS eventually become the standard of care? We need more data to answer that question. But so far, our findings are encouraging," said Chief Investigator Professor Marc Russo. # DTM™ SCS Therapy Research DataAnother trial was a randomized controlled trial conducted in Europe, as part of a post-market label study, involving patients with no history of prior spinal surgery. The study aimed to demonstrate the long-term benefits of DTM™ SCS therapy for chronic back pain patients who are not candidates for spinal surgery. The trial took place across 12 sites in four European countries and compared Medtronic's proprietaryDTM™ SCS Therapyand the efficacy of CMM traditional therapy.Medtronic's DTM™ programming mode is based on the differential gene expression of cells in pain and normal states. Within a stimulation cycle, it applies personalized multiplexing algorithms to different contacts of electrodes placed in different spinal segments (varying degrees of glial cell aggregation), providing stimulation parameters that combine low and high energy to maximize the restoration of cells from the pain state to the normal state.The data presented shows the results over 24 months, with key findings including:
DTM™ SCS therapy showed a better positive response to treatment at 12, 18, and 24 months in patients with chronic low back pain compared to CMM.
Patients using DTM™ SCS therapy at 24 months,Chronic Low Back Pain Reduced by 77%;
Using DTM™ SCS TherapyUp to 93% of patients with leg pain responded positively to the treatment., In addition, among these patients,Reduction in leg pain ≥50%;
According to the Oswestry Disability Index (ODI) assessment, patients using DTM™ SCS therapy experienced an average reduction of >26 points in the ODI score after 24 months.
After 24 months, 95% of patients were satisfied or very satisfied with DTM™ SCS therapy.
"The chief investigator of this study, Dr. Jan Willem Kallewaard, stated: 'This trial is the first randomized controlled trial of DTM™ SCS in Europe. These patients have very limited treatment options, and the trial has proven that DTM™ SCS therapy can help improve their quality of life.'" # About MedtronicMedtronic is a global leading medical technology company, founded in 1949, with its headquarters located in Minneapolis, Minnesota, USA. The company mainly focuses on providing lifelong treatment, diagnostic, and monitoring solutions for patients with chronic conditions such as cardiovascular diseases, neurological disorders, diabetes, and spinal conditions.On November 21, 2023, Medtronic announced its financial results for the second quarter of fiscal year 2024 (FY24), ended October 27, 2023. The earnings report showed that global revenue for the second quarter was $7.984 billion, representing a year-over-year increase of 5.3%, with organic growth of 5.0%. The company's core business demonstrated strong growth, with various regions and multiple business segments achieving increases. Revenue from the cardiovascular portfolio reached $2.923 billion, reflecting a year-over-year growth of 5.9%.Neuroscience Portfolio Revenue Reached $2.288 Billion, Increasing by 4.7% Year-over-Year; Revenue from the Medical Surgical portfolio was $2.142 billion, representing a 7.0% increase year-over-year; Diabetes revenue was $610 million, reflecting a 9.7% year-over-year growth. Editor-in-Chief | Zhao Qing Reviewed by | Yi He