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.

 

David Kim
David T. Kim practices intellectual property law, with a focus on patent prosecution and counseling in electronic and software technologies. Prior to joining the firm, he has worked at General Electric for five years as an embedded systems software engineer. In his engineering role, he designed and programmed inter-device communications, device drivers, interfaces, complex signal processing filters, and more contributing on both the hardware and software fronts. He helped GE launch numerous high-profile and successful products. During law school, David was a member of BU-MIT Entrepreneurship and IP Clinic and assisted student entrepreneurs in obtaining IP protections and counseling about legal ramifications of their business decisions.
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