Resources
Resources
Here are a variety of resources that you may find useful, including helpful educational materials for use when speaking with your patients about facet joint pain and their treatment options.
Online Physician Locator
List your practice on our online physician locator found on this site as well as on our consumer focused website, HelpingBacks.com. The locator helps referring physicians and patients and/or their caregivers get connected to you and your practice.
Sign up online or by using the Online Physician Locator Form (348 KB, PDF).
Indications For Use
The Stryker RF MultiGen (generator), in combination with the Stryker RF Electrodes and Cannulae, are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. Examples include, but are not limited to: Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.
The Stryker MultiGen Cable is intended for coagulation of soft tissues in orthopedic, arthroscopic, spinal, and neurosurgical applications in combination with the separately cleared Stryker RF MultiGen, Electrodes and Cannulae. Examples of procedures include, but are not limited to, Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, and Rhizotomy. The Stryker RF Intradiscal Adapter Cable is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The cable will be used with the previously cleared Stryker Intradiscal RF Generator and catheters such as Smith & Nephew SPINECATHR and ACUTHERM™ catheters.
Use of the Smith & Nephew SPINECATH Intradiscal Catheter and the ACUTHERM Decompression Catheter are appropriate for treating patients with herniations of intervertebral discs who would typically undergo automated or laser percutaneous lumbar discectomy.
Contraindications
The contraindications for the Stryker RF Intradiscal Adapter Cable would be the same as those for the catheter to which it is attached. The contraindications included in the instructions for use for the Smith & Nephew SPINECATH Intradiscal Catheter and the ACUTHERM Decompression Catheter are:
- Use of the SPINECATH Intradiscal Catheter is not appropriate for treating patients who present pain that is suspected to originate from structures other than contained herniated discs, or when free fragments or severe bony stenosis are present. In addition, patients presenting severely degenerative or disrupted discs should be excluded.
- Use of the Decompression Catheter is not appropriate for treating patients who present pain that is suspected to originate from origins other than herniated discs, or when free fragments or severe spinal stenosis are present. In addition, patients presenting with severely degenerative or disrupted discs should be excluded.
Downloads
MultiGen Product Brochure (1 MB, PDF)
Radiofrequency Patient Brochure (121 KB, PDF)
Radiofrequency Ablation Procedure Animation
Radiofrequency Ablation Procedure Animation (:47)
Part Number: 1000-000-146 Rev None
In elderly patients, back pain is frequently caused by a painful inflammation of a spinal facet joint. This inflammation irritates the surrounding medial branch nerves that, in turn, transmit pain signals to the brain. Through a minimally invasive procedure known as radiofrequency neurolysis, a tiny puncture is made into the skin and a small radiofrequency electrode is introduced. The electrode emits heat generating radio waves that disable the medial branch nerve. With the affected nerve disabled, pain signals are no longer transmitted to the brain.
Radiofrequency Ablation Procedure Walkthrough
Radiofrequency Ablation Procedure Walkthrough (1:50)
Part Number: 1000-000-146 Rev None
Stanley Golovac, M.D. – “A typical candidate that would be presenting themselves to a pain clinic for a radiofrequency neurolysis ablation procedure is usually an individual who is in their 50s, 60s, and 70s. The elderly age group usually suffers from a degenerative arthritic component. That arthritis develops into lumbar pain and neck pain. That develops into inflammatory changes within the joint, which is translated to the nervous system structure around the joint, therefore causing them to have pain with every movement they make. This can be remedied by a procedure of thermally heating up the medial branch nerve, which can relieve back pain for approximately two years or more. The typical process and treatment time for a radiofrequency ablation differs from site of treatment. If we’re going to be treating the cervical area it usually ranges from 15 to 25 minutes from start to finish. If we’re going to be treating the lumbar area it usually ranges from 20 to 25 minutes total time of treatment. The person who has had a radiofrequency ablation can always have this procedure repeated. It is something that creates an impaired nerve conduction system along the joint line of where the pain is experienced. So you actually can repeat this procedure, generally in a one to two year period of time without harming any nervous system structure around the joint. Relief typically is experienced from a radiofrequency ablation within a two to three week period of time after the treatment is complete. The area treated is going to have an inflammatory reaction around the site of treatment. Once that area has calmed down its inflammatory response to the treatment itself, the area should improve almost significantly and quite rapidly after the completion of that time period.”
Monopolar Procedure Animation
Multi-Gen Monopolar Procedure Animation (5:54)
Part Number: 1000-001-146 Rev None
Stryker MultiGen is indicated for use in various types of radiofrequency neurotomy procedures. Though for this example, we’ll demonstrate four thermal lesions with a simultaneous start on the lumbar spine. This particular neurotomy procedure works by disrupting the pain signals that are sent from the inflamed nervous tissue in the lumbar spine to the brain. To begin, up to four cannulae are carefully introduced in the area to be treated. Electrodes are then inserted into each cannula. On the MultiGen touch screen, the sensory phase of the procedure is active and the user has the option to modify the default or saved settings to more customized procedural settings. When setting adjustments are complete, the sensory stimulation tests are administered individually at each needle site. During the sensory test, the patient will respond to a slight pain sensation the closer the needles are to the problem nerves. Needles may need to be repositioned if these tests fail. After the sensory phase is complete, the motor button is selected and the screen changes from green to orange. The user again has the option to modify the default or saved motor stimulation settings. When setting adjustments are complete, the motor stimulation tests are administered individually at each needle site. The motor stimulation test will help confirm correct needle placement in all four locations while helping to ensure that each needle is not on a motor nerve. Though the lesions themselves will be run simultaneously, the sensory and motor tests are done individually at each location to help ensure accurate results. After the sensory and motor diagnostic tests have been confirmed, the user moves to the lesion screen and either selects thermal or pulsed radiofrequency or a combination of the two. For this demonstration, thermal radiofrequency is performed with simultaneous starts in all four locations. The user activates all four needle placements and presses the start button. As an added safety feature, the start button is pressed a second time to confirm that the user is ready to begin. High frequency current heats the surrounding nerve tissue creating four simultaneous lesions. MultiGen also allows either thermal or pulsed radiofrequency. In this example, we’ll show individual starts for thermal lesions. After the sensory and motor tests conclude, the user goes to the lesion screen, which defaults to the first needle placement, and presses start. The user confirms they are ready to begin by pressing the start button a second time and the procedure begins at the specified location. These steps are repeated for each needle placement. The user can wait for a lesion to finish before starting the next, or can use a staggered technique and begin at the next location while the previous is still burning. After all lesions are complete, the screen goes back to its default settings. In this final demonstration, we’ll use simultaneous starts in all four locations while performing pulsed radiofrequency through needles one and two and thermal radiofrequency through needles three and four. The needle placements and therapy types are chosen, the locations are locked into place, and the user presses start. After confirming that they are ready to begin by pressing start a second time, the thermal and pulsed radiofrequency procedures begin simultaneously at the specified location.
Parallel Bipolar Procedure Animation
MultiGen Parallel Bipolar Procedure Animation (3:23)
Part Number: 1000-001-146 Rev None
For patients with SI joint syndrome, Stryker MultiGen can also perform two parallel bipolar procedures, which allow for efficacious lesioning of the SI joint by creating larger lesions. To begin two parallel bipolar procedures, multiple cannulae are introduced into the sacroiliac joint. An electrode is then inserted into each of the four cannulae. With the sensory phase of the procedure active, the user locks together needles one and two by pressing the parallel button on the touch screen. At this stage, the user has the option to modify default or saved settings to more customized procedural settings using the MultiGen touch screen. The settings will be applied to both needles one and two. Individualized sensory stimulation tests are administered at the site of both needles. The patient will respond to a slight pain sensation the closer the needles are to the problem nerves. The needles may need to be repositioned if these tests fail. Needles three and four are then locked together and the sensory stimulation tests are administered in those locations. Once the sensory settings are confirmed, the user moves directly to the lesioning phase by selecting the lesion button on the MultiGen screen. Motor testing is not done in a bipolar procedure. Both sets of needles are selected. Start is pressed and then pressed again to confirm that the user is ready to begin. High frequency current heats the surrounding nerve tissue and creates two parallel bipolar lesions. The bipolar procedure is now complete. To create even longer lesions, these steps can be repeated with needle placements in a leapfrog fashion. Upon successful completion of the strip lesion, the cannulae are removed. Stryker MultiGen gives users the ability to customize their procedures for optimal patient results. It is the only radiofrequency generator on the market, able to handle up to four lesions simultaneously, and with independent control. Options for customization could include a single bipolar lesion, a mix of bipolar and single lesions and any combination of thermal lesions and pulsed radiofrequency.
MultiGen Features & Benefits Animation
MultiGen™ Radiofrequency Generator Overview (3:44)
Part Number: 1000-001-146 Rev None
Stryker MultiGen is a universal device used for minimally invasive pain treatment. Pain relief is achieved by the controlled heating of the area surrounded by the electrode tip. MultiGen provides a controlled thermal or pulsed lesion with a user-friendly touch screen. Buttons at the right of the screen allow the operator to change the phase of the procedure from sensory and motor testing to lesion modes. Screen color correlates to phase button color. MultiGen manages up to four lesions simultaneously and with independent control of time and temperature for each needle placement, enables the user to perform two parallel bipolar procedures concurrently, accommodates thermal and pulsed radiofrequency at the same time and uses a patented DualWave waveform technology to deliver controlled lesions. Unique safety procedures include a double-start mechanism to help prevent inadvertent starts, automatic temperature control for each cannula, along with dual temperature measurements and control for bipolar procedures. In addition, the MultiGen console comes with several notable storage advantages. Multiple customized physician settings streamline procedure preparation and users may save procedure specific information for later use. Anatomical information can be stored for each needle placement and various types of procedure information may be captured for immediate reference or printed for a review. The unique hand controller allows the physician direct control of the procedure while the large MultiGen screen and mobile hand controller enable the physician to operate the device from a distance. This provides convenience for the operating physician and means that staff members can focus their attention more closely on the patient and physician. And, with a sterile bag, the hand controller can be used easily in a sterile field. Stryker Monopolar Nitinol Electrodes are constructed from a nickel titanium alloy that sets the standard for durability and flexibility. Stryker’s self-grounding series Cannulae & Electrodes eliminate the need for a ground pad. The self-grounding series includes coaxial bipolar cannulae with localized energy control. And color-coded electrodes are available in a variety of lengths. The unique MultiGen cable supports both multi-lesion and parallel bipolar procedures, which reduce the overall time of SI joint procedures by creating larger lesions. For intradiscal lesioning, MultiGen provides pre-programmed time and temperature step profiles as well as on-the-fly adjustments. In addition, MultiGen conveniently connects to both AcuTherm and SpineCath catheters.
