Medical Device Daily

More speed. More power. More efficiency.

That’s what Advanced Neuromodulation Systems (ANS; Plano, Texas), the neuromodulation business of St. Jude Medical (St. Paul, Minnesota), says it put into its NeuroDynamix technology, an upgraded microchip for its rechargeable implantable pulse generator (IPG) system, the Eon.

Spinal cord stimulators, like the Eon, are similar in function and appearance to cardiac pacemakers, ANS said, except that the mild electrical pulses from the device are sent to electrical leads near the spinal cord instead of the heart and the device is implanted in the patient’s upper buttocks, rather than their chest. The pulses are intended to interrupt the pain signals as they travel to the brain, replacing painful sensations with a more pleasing sensation called paresthesia, the company said.

ANS highlighted the new technology and the Rapid Programmer 3.0, the clinician programmer that supports the Eon, at the annual meeting of the North American Neuromodulation Society (NANS; Glenview, Illinois) last week in Las Vegas.

“There was a very positive reaction at the North American Neuromodulation Society meeting to the new NeuroDynamix technology and the EON and to the Rapid Programmer 3.0,” Tom Hickman, VP of production management for ANS, told Medical Device Daily.

By putting more speed, power, and efficiency into the new technology, the Eon is able to offer a broader range of stimulation for the patient, Hickman said.

In June 2005 ANS expanded the U.S. market launch of the Eon. The device can power up to 16 independent electrodes in a dual eight-electrode lead configuration, according to the company (Medical Device Daily, June 22, 2005). The company reported receiving FDA approval for the device in March 2005 (MDD, March 21, 2005).

Hickman said the new NeuroDynamix technology enables the Eon system to process programming faster.

“The Eon is our flagship, 16-connector spinal cord stimulation system that really enables patients and physicians to have the most advanced spinal cord stimulation on the market,” Hickman said.

The Eon system is designed to aid in the management of chronic pain of the arms, legs and trunk, or pain resulting from failed back surgery. Although not a cure, ANS said spinal cord stimulation therapy can reduce pain that is the result of dysfunction or damage to the nervous system caused by injury, disease or localized trauma.

According to ANS, chronic pain is a largely under-treated and misunderstood disease that affects millions of people worldwide. The company said it is defined as moderate to severe pain that persists for one or more months longer than would generally be expected for recovery to a specific disease, injury or surgery. The NIH estimates that chronic pain affects more than 90 million people in the U.S. and costs about $79 billion a year in lost work time.

ANS said neurostimulation studies have shown that spinal cord stimulation systems can often reduce pain by 50% or more.

A spinal cord stimulation system includes a neurostimulator or generator — the device itself which is surgically implanted, battery-operated and operates like a pacemaker for pain; leads — one or more thin wires with several electrodes or contacts that carry mild electrical pulses from the device to specific segments of the spinal cord; a patient controller — a remote control device that turns the system on and off and allows patients to adjust stimulation within parameters set by physicians; and the programmer — a device that enables the doctor or clinician to adjust and fine-tune the stimulation programs.

According to ANS, the best candidates for spinal cord stimulation (SCS) systems are individuals with chronic, neuropathic pain who have unsuccessfully tried less aggressive pain therapies, ranging from exercise and over-the-counter medications to nerve blocks, systemic opioids and surgery. A number of factors affect whether a patient is a good candidate for SCS, the company said, including the patient’s diagnosis and medical history, as well as the severity, location and type of pain.

ANS calls its EON the most capable IPG on the market. The Eon with NeuroDynamix technology offers clinicians the speed, power, and efficiency to help sustain therapy long-term for virtually any patient – from unilateral single-site pain to challenging multifocal pain, ANS said.

In addition to treating chronic pain, some companies in the neurostimulation market are now using neurostimulation devices to treat movement disorders like Essential Tremor or Dystonia and psychological disorders including depression and obsessive-compulsive disorder. Companies involved in the neurostimulation space for these conditions include ANS, Medtronic (Minneapolis), Boston Scientific (Natick, Massachusetts), Northstar Neurosience (Seattle) and Cyberonics (Houston).

No Comments