Medtronic Receives FDA Approval for Inceptiv™, Its First Closed-Loop Rechargeable Spinal Cord Stimulator for Chronic Pain

Apr 29, 2024 00:01 CST Updated 00:01

Medtronic

Chronic Disease Medical Device and Therapy Developer

Source: Bone Future; Editor: Sophia

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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 activities.

# Inceptiv SCS System

Inceptiv SCS can sense biosignals 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 patient adjustment.

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 Options: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 Among Global Mainstream Companies' Spinal Cord Stimulators, Inceptiv Outperforms Other Spinal Cord Stimulators.

# Understanding the SCS Market Situation

Spinal Cord Stimulation, abbreviated as SCS, is a medical technology that uses electrical stimulation to relieve pain.

Implantable Spinal Cord StimulatorApplicable to a variety of pain disease treatment fields, including trunk pain, limb pain, neuropathic pain, visceral pain, spinal cord injury pain, refractory angina, etc.

Diabetic Peripheral Neuropathy (DPN), a common complication of diabetes, results from high blood sugar levels damaging peripheral nerves in the limbs, causing numbness, tingling, burning sensations, and more. An implantable spinal cord stimulator can provide long-term pain relief with minimal side effects, thusBecoming an important treatment option for diabetic peripheral neuropathy.

Industry Pain Points:

Traditional fixed-output SCS devices deliver continuous, gentle electrical pulses that disrupt pain signals before they reach the brain.

Fixed-output SCS systems may affect the patient's experience.

In daily life, certain movements such as laughing, bending over, or sneezing may cause brief discomfort due to overstimulation. This, in turn, can lead some patients to reduce the stimulation output of the device, resulting in a suboptimal treatment experience.

Vast market:

The global Spinal Cord Stimulator (SCS) market was valued at USD 2.25 billion in 2023 and is expected to grow during the forecast period from 2024 to 2030.8.70%with a compound annual growth rate,Reach $3.72 billion by 2030。

The demand for spinal cord stimulators (SCS) is mainly attributed to the increasing number of patients with chronic pain, as well as neuropathic pain in the shoulders, legs, and knees.

This technologically advanced device is non-invasive, eliminates targeted pain, reduces patient discomfort, has no side effects, and may be a driving factor for the growth of the global Spinal Cord Stimulator (SCS) market.

In addition, favorable government regulations for commercialization and product launches, along with the increase in the elderly population, are some of the factors driving the growth of the Spinal Cord Stimulator (SCS) market.

# Executive Evaluation

David Carr, Vice President and General Manager of Medtronic's Neuromodulation Business Pain Therapies:

"A new era of spinal cord stimulation technology is arriving. Inceptiv SCS is part of Medtronic's neuroscience portfolio. Patients with chronic pain should receive personalized and effective relief without compromising their ability to undergo MRI in the future. We are proud that Inceptiv SCS has received FDA approval, bringing good news to patients."

Medtronic to Launch Inceptiv in the U.S. Market in the Coming Weeks. The system was previously approved for sale in Europe and Japan.

# Medtronic SCS Product Overview

Medtronic'sltrel™3 Spinal Cord Stimulation SystemInitiated the clinical application of this therapy in China, and later developed a rechargeableRestoreSensor™And no charging requiredPrimeAdvanced™、The world's smallest and rechargeable spinal cord stimulation system compatible with 1.5T MRI scansIntellis™。

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, and overall performance has significantly improved, realizing a core transformation in charging technology.

In March 2024, the world's only system integrating multi-position instant sensation adjustment and high-performance 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.

About Medtronic

Medtronic (Medtronic, NYSE: MDT) was founded in 1949 and is headquartered in Minneapolis, Minnesota, USA. It is a global leading medical technology company with over 95,000 employees.

Medtronic's innovative solutions have expanded to 7More than 0 key disease areas, committed to providing lifelong treatment for patients with chronic diseases.Every second, two patients around the world benefit from Medtronic's medical technology or therapies.

Medtronic's main businesses includeCardiovascular, Medical Surgery, Neuroscience, and DiabetesFour business segments, includingThe highest proportion is cardiovascular.。What Does Medtronic Sell? A Comprehensive Overview of the Cardiovascular Product Line

Taking the 2023 financial report as an example, the total revenue was $31.227 billion, ranking first in the global medical device enterprise revenue. Among this, the cardiovascular business revenue was $11.573 billion, accounting for 37.06%, includingCardiac Rhythm and Heart Failure (CRHF), Structural Heart and Aorta (SHA), and Coronary and Peripheral Vascular (CPV)Three departments.

▲2023 Annual Report (Source: Company Official Website)

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Editor-in-Chief | Zhao Qing Reviewed by | Yi He