Renew^® and The Treatment of Complex Pain

Complex pain has long been considered a challenge to treat with spinal cord stimulation (SCS) because it can

• Involve multiple extremities and dermatomes
  
  
• Include an axial component
  
  
• Have a high probability of spreading
  
  
• Be nonresponsive to traditional SCS programming parameters and modes
  

For therapy to be successful in treating these complex pain elements, the SCS system must have the ability to precisely deliver stimulation, ensure broad coverage, and sustain the therapy. The Renew SCS system has the advanced technology, features, and capabilities to make it the system of choice for treating complex pain.

Precise Delivery of Stimulation

The literature indicates that small, closely spaced electrodes are more effective in selectively recruiting dorsal column fibers and minimizing unwanted dorsal root stimulation.^{(3,4,6,7,8,12)}

The Renew system supports the use of Octrode^® (octopolar) leads. Octrode leads

• Feature optimal electrode geometry (3 mm contact/4 mm spacing)⁽⁶⁾
  
  
• Offer greater precision in delivering stimulation to desired neural structures^{(3,4,6,7,8,12)}
  
  
• Minimize unwanted dorsal root stimulation^{(3,4,6,7,8,12)}
  

"Activation of DR (dorsal root) fibres and segmentary paresthesiae are favoured when stimulating monopolarly with a long cathode, whereas DC (dorsal column) fibre stimulation and large paresthesia coverage are favoured by a bipole or tripole (central cathode), with small contact lengths and spacings."⁽⁸⁾ 
—Holsheimer

Transverse Stimulation Fields

The ability to create a transverse stimulation field between dual leads greatly enhances targeting options and allows current to be directed selectively to the midline structures of the spinal cord.⁽⁶⁾

Renew^® allows cross talk between all parallel leads for generating transverse stimulation fields in all modes: MultiStim^®, PC-Stim^®, and Continuous.

"The pioneering work of Law has shown that stimulation in the low back can be consistently obtained only if one uses multiple arrays of closely spaced bipoles at T9-10. The best configuration involves two octapolar electrodes a few millimeters from the midline. With such a configuration one can create an electrical field that more selectively directs the current to the midline structures of the spinal cord."⁽⁶⁾
— Giancarlo Barolat, MD

Electronic Repositioning for Lead Migration

Lead migration is a common source of reoperation and revision of SCS therapy. The Renew system allows for electronic repositioning, which minimizes the need for reoperation:

• Octopolar leads have a lower revision rate compared to quadrapolar leads.^{(3,4,7,9,11,19)}
  
  
• Coverage of two vertebral segments enhances the ability for electronic, rather than surgical, repositioning of leads should cephalocaudal migration occur.

"If there is gross cephalocaudal movement of the array of electrodes outside the spinal target area, concordant paresthesia (necessary for pain control) is lost and may not be recaptured with simple reprogramming of differing electrodes in a quadripolar array, but might be recaptured if an octapolar array had been implanted."⁽¹⁰⁾
— Elliott Krames, MD

Multi-Programmability for Patient Empowerment

Multi-programmability facilitates broad coverage, provides flexibility in adapting to changing pain patterns, and enables patients to be involved in their therapy.^(3,4)

Renew^® offers these multiprogrammable features:

• Up to 24 available programs delivered in Continuous or MultiStim mode
  
  
• MultiStim mode to automatically cycle up to eight stim sets for diffuse pain sites, increasing paresthesia overlap^(3,4)
  
  
• PC-Stim^®, which allows patients to manually select programs for greater control
  

"PC-Stim and M-Stim mode SCS increase paresthesia overlap, reduce pain scores, and improve patient satisfaction with SCS therapy."⁽³⁾
— Kenneth M. Alo, MD

Wider Ranges and Indefinite Battery Life

Complex pain patients may require multiple active electrodes and higher energy outputs to reach and sustain therapeutically effective stimulation levels. The Renew system has the parameter ranges and battery power to support long-term patient needs:

• Indefinite device longevity due to an external, rechargeable battery
  
  
• Wide parameter ranges and multiple programs to sustain optimal levels of stimulation coverage for complex pain
  
  
• Frequency ranges up to 1,500 Hz for patients who prefer higher ranges^{(3,4,7,11,19)}
  

"Patient compliance may be enhanced by the device’s (IPG) convenience; however, concern over battery longevity may compromise daily usage by the patient and adjustment of stimulation parameters by the physician."⁽¹⁸⁾
— Richard North, MD

Multiple Dermatomes

Complex pain patterns often require lead arrays and electrode combinations that cover multiple segments and dermatomes. Renew’s compatible leads

• Cover up to two vertebral segments
  
  
• Enhance sustainability of coverage with a longer electrode span
  
  
• Include Octrode^® leads, which feature optimal electrode geometry and allow specific, multiple site targeting, including low back and bilateral leg pain

"Since a larger area of stimulation increases the likelihood of completely covering the painful segment, combinations that cover a large area of the body are usually more desirable."⁽⁵⁾
— Giancarlo Barolat, MD

Multiple Configurations

Complex pain patterns can be multifocal, requiring multiple lead configurations.
The Renew^® system can be used with one-, two-, three-, or four-lead arrays—all with independent control. The Renew system’s multiple lead arrays allow full coverage of upper and lower extremity pain concurrently.

Multiple Programs

Many complex pain patients need advanced programming options to attain successful coverage:

• MultiStim^® can automatically cycle up to eight stim sets for diffuse pain sites, increasing paresthesia overlap^(3,4,7,21)
  
  
• MultiStim and PC-Stim^® provide multiple options for greater patient control^(3,4,21)
  

"Our data indicate a beneficial relationship between the number of activated programs and pain relief. In our practice, few patients have pain in just one area. It is almost axiomatic that a single program is inadequate to treat the complex pain patterns that are often seen in chronic pain patients." ⁽²¹⁾
— Kenneth M. Alo, MD

Product Information and Specifications