FDA Approves Advanced Spinal Cord Stimulator

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a new spinal cord stimulator developed by Medtronic that can be managed, tracked and updated remotely on a Samsung Galaxy tablet.

The Intellis stimulator is designed for patients with chronic, intractable pain of the trunk and/or limbs.

The Intellis platform can track patient activity 24/7 on the Samsung Galaxy Tab S2 tablet, enabling physicians to personalize the settings for individual patients and monitor their progress using Medtronic’s Evolve software system. 

"The launch of the Intellis platform isn't just about a new device, but about combining cutting edge hardware with optimal therapy through the Evolve workflow to enable personalized, long-term pain relief," said Marshall Stanton, MD, president of Medtronic's Pain Therapies division.

“The Intellis platform was designed based on what is most important to patients and physicians. We considered the entire patient journey - starting with the primary goal of optimal pain relief and access to important diagnostic tools, like MRI, to ease of use with simplified programming, faster recharge and a smaller implant."

MEDTRONIC PHOTO

MEDTRONIC PHOTO

Spinal cord stimulators (SCS) are often considered the treatment of last resort for chronic back and leg pain, because the devices have to be surgically implanted near the spine and connected to batteries placed under the skin. The implants send electrical impulses into the spine to mask pain.

Some patients find the stimulators ineffective and have them removed. According to one study, only about half of patients who received a traditional SCS device have a 50 percent reduction in their back and leg pain. New technologies are being developed to make the devices smaller, more effective and easier to recharge.

Medtronic says Intellis is the world's smallest fully implantable SCS neurostimulator. Its battery can be fully recharged from empty to full in about one hour and physicians can estimate recharge intervals based on therapy settings. Software upgrades are also easier to get through Samsung Galaxy tablets.

"We are excited to partner with Medtronic in their aim to simplify programming, and streamline therapy management with the Intellis platform," said Dr. Dave Rhew, chief medical officer and head of Healthcare and Fitness for Samsung Electronics America. "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."

One of the first implantation procedures using the Intellis platform was performed at Duke University Medical Center.

"Chronic pain is challenging to manage. Having real-time data can provide more information about patients' quality-of-life changes. This platform represents a welcome new option for managing some kinds of chronic pain," said Lance Roy, MD, a pain medicine specialist at Duke University Medical Center.