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.
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