Medtronic’s Intellis and Vanta Neurostimulators Receive FDA Approval for DPN
Medtronic announced that its Intellis™ neurostimulator and the Vanta™ neurostimulator have both received approval from the U.S. Food and Drug Administration (FDA) for the treatment of chronic pain associated with diabetic peripheral neuropathy (DPN), in a January 24, 2022 press release. The approval grants patients suffering from DPN access to both products within Medtronic’s spinal cord stimulation (SCS) portfolio. The IntellisTM neurostimulator is rechargeable whereas the VantaTM neurostimulator is recharge-free .
DPN, also referred to also as painful diabetic neuropathy (PDN), is a neurological disorder that impacts about 30% of individuals with diabetes, according to the press release. DPN occurs when high blood sugar levels damage nerves causing numbness, burning, or stabbing pain. Charlie Covert, a Medtronic vice president and general manager, views the new approvals as another example of Medtronic’s expertise:
DPN is a significant challenge for patients with diabetes, leading to disability and a diminished quality of life . . . This new indication enables us to apply Medtronic’s more than 40 years of proven SCS experience, as well as the company’s deep diabetes expertise, to deliver better care to even greater numbers of diabetes patients
According to the press release, Medtronic estimates that the US market revenue for SCS treatment of chronic pain associated with DPN is approximately $70 million and expects market revenue to grow to $300 million by fiscal year 2026.
With the new approval, Medtronic’s IntellisTM and VantaTM neurostimulator products now join Nevro’s HFXTM for PDN as the only SCS devices with FDA approval for treatment of DPN/PDN. Nevro’s Chairman, CEO, and President, D. Keith Grossman, responded to the FDA’s approval of the IntellisTM and VantaTM neurostimulators in a press release, stating:
PDN represents a very large potential market, and having another competitor validate this large opportunity speaks to its attractiveness.
Nevro announced the FDA’s approval of its HFXTM on July 19, 2021.
Medtronic Pain Management Device Approved by FDA
Medtronic announced FDA approval and U.S. launch of its Intellis Platform for the management of certain types of chronic intractable pain. According to Medtronic, the Intellis platform features the world’s smallest implantable spinal cord stimulator (SCS), which includes an implantable pulse generator that looks like an older-style pacemaker, but with wire leads that delivers mild current to a spinal vertebra. The Intellis, and other SCS systems deliver, neurostimulation at the spinal cords to prevent pain signals from reaching the brain.
The MIT Technology Review reports that SCS systems carry promise because they represent an alternative to opioid-based pain management. It is estimated that more than 20,000 Americans a year die from overdoses of prescription pain drugs. Government and industry alike recognize the gravity of the opioid issue. FDA Commissioner Dr. Scott Gottlieb has stated that opioid abuse is is taking a staggering human and economic toll and is therefore a top priority. Industries are also responding with ever-improving SCS systems (Medtronic’s pain-therapies business show $825 million in revenue during the company’s 2017 fiscal year).
According to Medtronic, the Intellis system allows physicians to better address the subjective and personal nature of patient’s chronic pain. Based on recorded and tracked patient activity, including body positions and how patients self-administer their therapy, Intellis allows a physician to program and manage pain therapy for each patient with a wirelessly connected Samsung tablet.
Samsung Chief Medical Officer Dr. Dave Rhew said:
We are excited to partner with Medtronic in their aim to simplify programming, and streamline therapy management with the Intellis platform . . . Samsung’s Galaxy tablets — secured by the HIPAA-ready Samsung Knox mobile security platform — will support future Medtronic therapies and over the air (OTA) software upgrades to ensure clinicians using Intellis have access to the most up-to-date solutions.
Medtronic is not the only industry player to explore cross-industry partnership: at least one of its competitors, Abbott (which acquired St. Jude and its line of chronic pain treatment devices in January, 2017) offers SCS devices featuring controllers made by Apple.
Stimwave’s Wireless Pain Relief SCS System Receives FDA Clearance
Fort Lauderdale-based company Stimwave Technologies announced today that its eight-electrode wireless, micro-technology neuromodulation device for relief of chronic back and leg pain received FDA 510(k) clearance. The Company plans to begin full nationwide commercialization January 1, 2016.
According to Stimwave, its Freedom-8A Spinal Cord Stimulation (SCS) System is the world’s first fully-programmable wireless SCS neuromodulation device that eliminates the need for painful tunneling and internal battery placement within the body. Stimwave states that its device features a compact 0.4 cc profile and eight electrodes placed near nerve fibers around the dorsal aspect of the spinal column. The device is said to deliver selected pulses of energy to the electrodes to alter the transmission of pain signals to the brain. Additionally, Stimwave notes that its device is implanted in an outpatient setting through a standard needle, eliminating the need for general anesthesia or a large surgical incision.
Dr. David Kloth, M.D., medical director of the Connecticut Pain Care Center and author of Pain Wise, stated:
“Patients’ needs in pain management are complex and unique. The Freedom-8A SCS System is a first-of-its-kind product and offers a wide variety of advanced programming features, polarity selection options for up to eight separate electrodes per device, in the body in the least invasive fashion ever offered. This advancement will provide clinicians with a multitude of options and allow patients the most amount of freedom over their pain management.”
According to the press release, Stimwave is currently investigating the safety and efficacy of even wider programmability options, such as high-frequency programming up to 10,000 Hz, in an FDA approved clinical trial.
St. Jude Medical Acquires Spinal Modulation, Inc.
St. Jude Medical recently announced that it has completed the acquisition of Spinal Modulation, Inc. In June of 2013, St. Jude invested $40 million in Spinal Modulation for which it received an exclusive option (now exercised) to purchase the company for a maximum of $300 million, plus milestone payments. According to St. Jude Medical’s earlier press release, St. Jude Medical agreed to pay Spinal Modulation $175 million upon closing with milestone payments due upon FDA approval of Spinal Modulation’s Axium Neurostimulator System.
St. Jude Medical describes the Axium system (shown to the right) as a form of spinal cord stimulation (SCS) that targets a neural structure within the spine called the dorsal root ganglion (DRG). The DRG contains the primary sensory neurons that transmit pain signals from the peripheral nerves to the brain. The system uses an implantable medical device to deliver mild electrical pulses to the DRG. These pulses mask or interrupt pain signals as they travel to the brain.
According to St. Jude,
[w]ith the closing of the acquisition, St. Jude Medical has become the only medical device manufacturer in the world to offer radiofrequency ablation (RFA), spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation therapy solutions for the treatment of chronic pain.
According to its website, St. Jude Medical is a global medical device company, headquartered in St. Paul, Minnesota, offering a wide array of products in diverse fields.
Spinal Modulation, Inc., headquartered in Menlo Park, California, focuses on providing treatment options for patients suffering severe chronic pain.
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