Medtronic (Minneapolis) reported receiving FDA approval of its Restore Rechargeable Neurostimulation System, via PMA-supplement, about a week ago, but the system will receive an aggressive, first-time showcasing during this week’s annual meeting of the American Association of Neurological Surgeons (AANS; Rolling Meadows, Illinois) at the Ernest N. Morial Convention Center in New Orleans, ongoing through Wednesday.

Medtronic bills the Restore System as a new treatment option for people suffering from complex, difficult-to-treat chronic pain. It offers, the company says, therapy for those requiring high-power stimulation for pain relief, and it features “the most powerful and longest-lasting rechargeable battery available.”

Daniel Millikin, senior product marketing manager for Medtronic, says of the next-generation device in this product line that “stimulation is still stimulation – you’ve still got leads that produce stimulation.” But that the system’s ability to provide higher levels of stimulation – and the rechargeable technology – makes it “a whole new platform and gives us access a patient group we have been able to effect before through standardized implantable pulse generators,” he told Medical Device Daily.

The battery of the Restore stimulation system can last up to nine years, exceeding, the company says, “any other rechargeable spinal cord stimulator on the market.” And when power levels are low, an alarm/icon system signals the need to recharge. This needs to be just once per month, compared to other stimulation devices needing recharge as frequently as once a week.

The device, about the size of a stopwatch, is implanted under the skin. And up to two leads – with eight electrodes each – deliver electrical pulses to the spine. The impulses then serve to block the transmission of pain from the spine to the brain.

David Caraway, MD, PhD, medical director of the TriState Regional Pain Management Service at St. Mary’s Hospital (Huntington, West Virginia), notes that the provision of 16 leads – at least double that of other neurostimulation devices – allows a much greater level of options to physicians for programming impulses to the spinal chord, based on the type of pain and the patient’s particular needs.

Additionally, he said that up to four of these programs, preset by the physician, allow the patient, using a hand-held programmer, to “toggle” from one to another during the day to match the delivery of impulses with different every-day situations, such as sleeping or exercising.

This, he told MDD, gives the patient a much greater sense of responsibility and self-control in providing his or her own therapy.

With the Restore, he said, “The patient controls the pain; the pain doesn’t control the patient. And by delivering a high level of sustainable power, this new rechargeable device will provide relief to many who suffer greatly and may be functionally impaired by pain.”

Carraway said that the Restore serves to underline the increasing opportunity that device technology has in penetrating a market that has generally been dominated by drug therapies, but with pharmaceuticals so often coming with their historically high levels of side effects, the worst being addiction, he noted.

Among the types of persistent pain for which the Restore is designed, he said, is pain resulting from back problems, such as degenerated or slipped discs, often emanating into the legs – and frequently unrelieved by surgery – or the result of simple trauma.

Medtronic says that the cases of debilitation from chronic pain can range, at some times, to 25% of the U.S. population, resulting in effects ranging from hundreds of millions of lost workdays, millions of physician visits and, at the very worst, suicides.

Restore joins the Medtronic portfolio of neurostimulation and pump pain therapies available to clinicians specializing in the management and treatment of chronic pain.

Millikin said that pain physicians would be the center of the company’s target market but that “pretty much any physician can use [Restore] – it comes down to the patient that walks through the door. The patients haven’t changed, the physicians haven’t changed; this is another product for the physician to utilize to effect pain relief.”

He says FDA approval will now lay a firmer groundwork for reimbursement by Medicare, which the company is currently working on.

Also at the AANS conference:

Varian Medial Systems (Palo Alto, California) is exhibiting is featuring its advanced X-ray imaging and treatment technologies for image-guided radiosurgery.

Varian Surgical Sciences, an organization created within Varian Medical earlier this year, is exhibiting its image-guided robotic radiosurgical solutions built around the company’s new Trilogy Stereotactic System and On-Board Imager device.

The Trilogy System, introduced in 2004, enables the treatment of small areas in the brain and other parts of the body with precisely placed beams.

Lester Boeh, vice president for Varian Medical Systems and manager of Varian Surgical Sciences, said, “This is the most powerful, precise and versatile treatment solution ever developed, and it represents the future for patient treatment delivery, improving the quality of care while increasing efficiency and lowering the cost of treatment.”

Facilities currently using the Trilogy accelerator include Emory University (Atlanta), Vanderbilt University (Nashville, Tennessee), M.D. Anderson Cancer Center (Houston), Providence Medical Center (Kansas City, Kansas) and Providence Hospital (Mobile, Alabama).

Founded in 1931 as the Harvey Cushing Society, the AANS says its annual meeting is the largest gathering of neurosurgeons in the world. It is hosting more than 6,000 attendees, with about 2,800 medical professionals.

The program includes 40 practical clinics, 20 general scientific sessions, 80 breakfast seminars, 135 oral abstract presentations and more than 500 poster presentations. About 220 companies are slated to exhibit, beginning today.