With the promise of more device programming options, Medtronic (Minneapolis) last week reported FDA approval of Activa RC and Activa PC, two deep brain stimulation (DBS) devices used to treat the symptoms of advanced Parkinson's disease and essential tremor.

Medtronic DBS therapy delivers small electrical pulses to precisely targeted areas within one or both sides of the brain to help patients achieve greater control over disabling body movements, according to the company. The new devices will be available in the U.S. in June.

Both Activa RC and Activa PC devices provide bi-lateral stimulation (to both sides of the brain) and offer a more advanced approach to device programming, and additional tools for capturing history relevant to the patient's therapy, Medtronic says. New programming options provide greater ability to fine tune the stimulation field and give patients more options to optimize their settings compared to previous DBS devices. Additionally, information about patient symptoms and side effects can be stored in the device, which is helpful to physicians in determining the best programming settings for each patient, according to Medtronic.

Leo Verhagen, MD, PhD, medical director of the Surgery Program for Movement Disorders at Rush University Medical Center (Chicago), told Medical Device Daily that the programming features of these new devices are really what set them apart from previous DBS devices for patients with Parkinson's disease or essential tremor.

These next-generation devices also have a hand-held patient programmer, which features new advancements, including an LCD screen that provides valuable information such as the level of battery charge. The programmer allows patients to alternate between stimulation settings pre-programmed by their clinician so they can customize their therapy based on their activity. Previously, the patient would have had to wait until their next appointment to get their device settings tweaked, Verhagen said.

"The Activa RC and Activa PC devices offer exciting new programming features that can further enhance the therapeutic benefit of deep brain stimulation for patients with Parkinson's disease and other movement disorders," Verhagen said. "This advanced technology will offer more programming features that allow doctors to optimize stimulation effects and also provide options for patients to better control and monitor their therapy settings."

Medtronic said a primary cell (non-rechargeable) battery that does not require any regular maintenance from the patient to provide continuous stimulation for multiple years powers the Activa PC. The Activa PC neurostimulator represents a 20% reduction in size and weight compared to previous bi-lateral devices and has similar battery life, according to the company.

Activa RC is the first rechargeable DBS neurostimulator in the world, Medtronic noted, and lasts for nine years before replacement is necessary. Patients need to "plug themselves in" for a few hours at home on a regular basis to recharge the device depending on their stimulation settings, Verhagen said. Medtronic said the Activa RC, also significantly smaller than previous bi-lateral devices, is expected to benefit select patients who have high-energy stimulation requirements. For those patients, the device may eliminate the need for frequent battery changes, Verhagen said.

Both Activa RC and Activa PC were approved in Europe in August 2008. Activa PC has become the most widely used device in Europe for bi-lateral DBS therapy, according to Medtronic.

"Activa RC and Activa PC expand our family of DBS therapy devices to give patients and physicians the flexibility they need to customize a successful DBS treatment program to manage the debilitating symptoms of movement disorders like Parkinson's disease and essential tremor," said Richard Kuntz, MD, president of the Neuromodulation business and senior VP at Medtronic. "These devices also accentuate Medtronic's place as the long-time pioneer and leader in neuromodulation technology, represented by the only commercially available DBS therapy system in the U.S., 20 years of DBS experience, and an ongoing commitment to further pursuit of technological innovations to improve the lives of patients."

Medtronic launched DBS in the U.S. in 1997 for the treatment of essential and Parkinson's tremor. Since the initial launch of DBS therapy, the list of indications has grown to include management of the symptoms of advanced Parkinson's disease (approved in 2002), dystonia (approved under a humanitarian device exemption in 2003), and obsessive-compulsive disorder (approved under an HDE in 2009). The company says that more than 60,000 people worldwide have received Medtronic DBS therapy to date.

The DBS therapy system consists of implantable and external components. Implanted components of the system include the lead, which is a thin coiled wire with electrodes on the end that are placed in a specific target in the brain; the extension wire to connect the lead to the neurostimulator; and the neurostimulator, a pacemaker-like device placed beneath the skin in the chest that produces the tiny electrical pulses that are believed to block abnormal brain function that causes disabling movements.

External components of the system include the physician programmer (N-Vision), which is used to adjust stimulation programming settings; and the hand-held patient programmer that the patient uses to turn the neurostimulator on or off, check the battery status, or choose their stimulation settings within a range of preset options. With the physician programmer, Medtronic said a clinician can non-invasively adjust the electrical pulses and transmit them via radio telemetry to the implanted neurostimulator.

Activa RC uses a wearable charging system, which includes the patient controller, recharge antenna, and belt to hold the components in place while re-charging. A patient can move about while recharging, which typically takes a couple of hours every two weeks, according to Medtronic.