Medtronic Announces New 12-Month Clinical Data Demonstrating Sustained Efficacy of Inceptiv™ Closed-Loop Spinal Cord Stimulation System for Chronic Back and Leg Pain

Feb 08, 2025 08:08 CST Updated 08:08

Medtronic

Medical Device Manufacturer

At the end of January 2025, Medtronic announced the release of the latest clinical data for its Inceptiv Closed-Loop Spinal Cord Stimulator (CL-SCS) system, demonstrating significant and sustained efficacy of the device in treating chronic low back and leg pain. Siyu has distilled the key highlights for industry readers' reference.

# Clinical Effect

At 12 months, the mean reduction in low back pain Visual Analog Scale (VAS) pain score was 67%.
87% of subjects showed significant improvement in three or more quality of life (QoL) domains.
76.9% of patients experienced ≥50% relief in back pain, and 79.3% of patients experienced ≥50% relief in leg pain.
56.4% of patients experienced ≥80% relief in back pain, and 58.6% of patients experienced ≥80% relief in leg pain.

# Technical Features

The Inceptiv system is Medtronic's first SCS device to offer closed-loop functionality, with the following features:

Can sense bio-signals along the spinal cord and automatically adjust stimulation in real time.
Using Evoked Compound Action Potential (ECAP) technology, adjust 50 times per second.
As of January 2025, it is the only FDA-approved closed-loop SCS capable of full-body 3T MRI scans.
Is the world's smallest and thinnest fully implantable SCS device

# Other Advantages

50% of patients are able to reduce or discontinue the use of opioids.
Patients need to adjust the stimulation amplitude only once every 30 days on average.
Multiple waveforms can be selected, including Medtronic's proprietary DTM SCS therapy.
Patients can receive guidance through the mobile application CareGuidePro.

These data indicate that the Inceptiv closed-loop SCS system has significant effects in long-term relief of chronic pain, improvement of quality of life, and reduction of medication use, representing an important advancement in the field of spinal cord stimulation therapy.

# About Medtronic Inceptiv SCS System

On April 26, 2024, Medtronic (NYSE:MDT) announced itsInceptiv™ Closed-Loop Rechargeable Spinal Cord Stimulator (SCS)Has received FDA approval for the treatment of chronic pain.

Inceptiv is Medtronic's first spinal cord stimulator (SCS) device to offer closed-loop functionality, capable of sensing bio-signals from the spinal cord and automatically adjusting stimulation in real time to align treatment with daily life activities.

Inceptiv SCS can sense biological signals and is equipped with dedicated circuits and proprietary algorithms to detect ECAP (Evoked Compound Action Potentials), which are signals generated by the spinal cord in response to electrical stimulation.

Product Features:

Real-time adjustment:Inceptiv SCS can sense the body's response to stimulation 50 times per second and immediately increase or decrease the stimulation without the need for the patient to make adjustments themselves.

For easy inspection:Inceptiv SCS is currently the only spinal cord stimulator that allows full-body 1.5T and 3T MRI scans, and it is the world's smallest and thinnest fully implantable SCS device.
Medtronic statistics show that nearly 84% of SCS implant patients require at least one MRI examination within five years after implantation.
Multiple Choices:Inceptiv SCS allows patients to choose from multiple waveforms, including Medtronic's proprietary DTM™ SCS therapy, which demonstrated a 12-month response rate of 84% in a large multicenter randomized controlled trial (RCT).
Lightweight and Compact:Inceptiv is the world's thinnest spinal cord stimulator, with a thickness of only 6mm, and it takes just 1 hour to fully charge.
Comparative Advantage:Differences in spinal cord stimulators among mainstream global companies, Inceptiv also outperforms other spinal cord stimulators.

# Medtronic More SCS Products Overview

Including:ltrel™3 Spinal Cord Stimulation System, RechargeableRestoreSensor™And no charging requiredPrimeAdvanced™、The World's Smallest and 1.5T MRI-Compatible Rechargeable Spinal Cord Stimulation SystemIntellis™。

Among them, Intellis™ is equipped with excellent performanceOverdrive™ Battery Technology, achieving the effect that the battery capacity remains over 95% after 9 years of use. The charging efficiency is 3 times faster than traditional lithium-ion batteries, with overall performance significantly improved, realizing a core transformation in charging technology.

In March 2024, the world's only system integrating multi-position instant sensation regulation and high-efficiency patented stimulation technology DTM™-ERecharge-Free Spinal Cord Stimulation SystemVanta™Launched in China with the most comprehensive pain indications approved, including painful diabetic neuropathy in the lower limbs.