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.

FDA Order Stops Production of Medtronic Pain Pump

By Pat Anson, Editor

The U.S. Food and Drug Administration has filed a court order against medical device maker Medtronic ordering it to cease production and distribution of its SynchroMed II pain pumps.

Defects in the surgically implanted pumps, which are used to treat patients with chronic pain, cancer and severe muscle spasms, have been blamed for over a dozen deaths. The devices either lost power or inadvertently injected patients with too much or too little medication. The pump delivers analgesic drugs directly to the spinal fluid of pain patients.

Under the FDA's consent decree with Medtronic, the company will stop production of the SynchroMed II pump at its manufacturing plant in Columbia Heights, Minnesota. Medtronic will also retain a third-party expert to help develop and submit plans to the FDA to correct manufacturing and design problems. The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions of the consent decree.

The FDA first approved the SynchroMed II pumps in 2004. Between 2006 and 2013, FDA investigators conducted five inspections at Medtronic’s production facilities, resulting in three warning letters notifying the company of major violations. The violations included inadequate processes for identifying quality control problems, failure to document design changes, and failure to ensure that finished products meet design specifications.

“The FDA expects that all patients will be treated with safe, effective and high-quality medical devices,” said Jan Welch, acting director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “We will continue to stop distribution of devices made by firms that fall short of regulatory requirements.”

Over 200,000 SynchroMed pumps have been implanted worldwide, according to Medtronic, but the devices are not being recalled. Patients who experience a sudden change in their pain levels or hear a device alarm are being urged to contact their physician immediately.

“The agreement does not require the retrieval of any Medtronic products. With this announcement there is no new information to share about the safety and performance of the SynchroMed drug infusion system. Patients with the SynchroMed drug infusion system do not need to change their current course of therapy, have the pump removed, or take any other action as a result of this agreement,” the company said in a statement.

"We are committed to the highest level of quality, and have pursued significant efforts in recent years to enhance the performance of the pump and to address the FDA`s expectations," said Tom Tefft, senior vice president and president of Neuromodulation, which is part of the Restorative Therapies Group at Medtronic.