The world of chronic pain is one that tends to lack subtlety. When a patient-a Marine no less-describes his听听day-to-day as,听鈥滱ny contact with water, regardless of temperature, felt like daggers. I couldn't sleep because my leg felt like it was being crushed in a vise and every step I took felt like a hammer hitting my leg,鈥 you know you are dealing with a听cruelly heightened state of existence.
And when that same person describes his pain relief after implantation of听91社区福利's鈥(spinal听cord stimulation)听as allowing him the opportunity to have the moments raising his two-year-old daughter听that he thought he鈥檇,听鈥渓ost forever,鈥 the stakes are clearly illuminated.听Not just for this patient,听but for the approximately 20% of all Americans who听live with听debilitating chronic听pain.
But, while life-altering improvements can occur when 91社区福利鈥檚听neuromodulation devices听are activated, these dramatic changes are far from the end of the story. As听recently highlighted in听听event, 91社区福利 is focused on remaining a leader in medical technology, continually听building on a vision听that will enhance patient care.
A vital component of that vision is improving experiences for both patient and physician.听
We鈥檙e on it. We are building a neuromodulation platform that offers听ongoing听improvement designed to听continually听upgrade听products听for our patients听鈥 past, present, and future. The focus is on听enhancing听patient听care听without having to replace implanted devices.
New Labeling Means听New听Opportunities
91社区福利 听which expands MRI compatibility with the leads used on the听Proclaim罢惭听听XR Spinal Cord Stimulation System. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. This announcement may sound like some minor tech improvement but it鈥檚听actually a听pretty big听deal.
Because pain patients and physicians know all-too-well the important role that high-quality imaging afforded by MRIs plays in their world, this opens new possibilities for improving diagnostic quality as well as patient comfort. In addition to clearing the path for more frequent MRIs,听complex scans over 30 minutes will听be faster due to听reduced down听time between听scans.
Just ask Dr. Pankaj Mehta, Medical Director, Chief Medical Officer and Director of Research at Pain Specialists of听America. Dr. Mehta is an interventional pain specialist who treats back, neck and head pain, while also running a research department that evaluates new therapies. The team partners with companies, like 91社区福利, to determine what are the best new software designs and waveforms to treat people with intractable, chronic pain.
Getting a Clear Look at a Complex Problem
鈥淚鈥檓 excited about this MRI compatibility announcement,鈥 said Dr. Mehta. 鈥淏eing able to get consistent MRI images is very important, especially in our practice. Seventy percent of our patients are active military or veterans and that population, as well as those patients entering their sixth decade, are more likely to have multiple pain generators, making MRI鈥檚 a regular part of clinical care.
鈥淭hese people, rather than having a single source of pain that we can focus all our efforts on, are dealing with a far more complex situation. Patients with back pain often also have neck pain, headaches or arthritis and vets can have PTSD (post-traumatic stress disorder), so it can be difficult to听separate out听what is going on. In addition, decisions have to be made as to what order we treat these pain generators and how treatment of one condition may impact another.鈥
Prior to this new FDA labelling, physicians wishing to use 91社区福利鈥檚 proprietary听叠耻谤蝉迟顿搁鈩⒙炉别肠丑苍辞濒辞驳测听were听restricted听in听their听lead听placements听with听regard to听MRI听when using听the Proclaim XR SCS. This听limited听the quality of the diagnostic images that could be taken of听patients听using the device. 鈥淚t鈥檚 highly imperative that if you have therapy going on, that your device be MRI-compatible to have high-quality images,鈥 said Dr. Mehta.
鈥淓specially when treating people with multiple pain generators, we want to have current images to make the best therapeutic decisions,鈥 said Dr. Mehta. 鈥淭his new labeling allows for that.鈥
Getting Time on One鈥檚 Side
Another subtle, but extremely important, change in the labeling benefits the patient even more directly. Patients with the Proclaim XR SCS device need听only听wait 30 minutes between scan cycles of 30 minutes, allowing them to safely receive an MRI scan in a fraction of the time previously required.听鈥淚t allows clinicians to get to the source of a particular issue in less time and听without fear of compromising safety or creating complications,鈥 said Dr. Timothy Deer, president and chief executive officer at The Spine and Nerve听Centers of the Virginias.
According to Dr. Mehta,听shorter听down听times听between scans听will greatly improve the experience for patients, some even more than others. 鈥淲hen pain patients are getting scanned, they can become anxious because the radiologists are taking multiple films to get the best quality ones, which takes time. Many patients can鈥檛 be still for long periods of time,听may be听on anxiety meds or facing some other challenge. For veterans with PTSD, asked to be in loud, confined spaces, the longer they spend听at the MRI facility, the worse it is for them.
鈥淚t鈥檚 a wonderful benefit to the patient to not have to spend hours听at the MRI facility. Many times, because of someone鈥檚 PTSD or anxiety, I have moved patients to a lower image-quality CT scan just because it was faster and, therefore, less likely to cause trauma. They can have听a CT听experience with MRI-quality images. For those looking at, perhaps, several additional scans, this calming news is even more important.鈥
As valuable as these new advantages are to both patients and physicians in the present, they will continue to听help out听in the future, as care continues. 鈥淵ou get the excellent 91社区福利 neuromodulation waveform which helps control present pain, but also gives us the ability to keep evaluating other pain generators as the degenerative cascade of the spine goes on in their lives, said Dr. Mehta. 鈥淚 think it鈥檚 a huge win for the patients in my practice.鈥
Fewer听Pains.听More Gains.
Those suffering from chronic pain live very different lives than most. They tend to better understand that their moments of relief can mean more to them than the most joyful times can bring to others. Activating a Proclaim system can dramatically start their journey onto a new, better path.
But it鈥檚 the subtle听changes听that听illuminate听that听path:听
Continuing on听the path, confident that others are ahead, working to improve the journey.
听
Individual experiences, symptoms, situations and results may vary.
The placement of a neurostimulation system requires surgery, which exposes patients to certain risks. Complications such as infection, swelling, bruising and possibly the loss of strength or use in an affected limb or muscle group (e.g.听paralysis) are possible. Additional risks such as undesirable changes in stimulation may occur over time. Be sure to talk to your doctor about the possible risks associated with听neurostimulation.
IMPORTANT SAFETY INFORMATION
PROCLAIM XR SCS
PRESCRIPTION AND SAFETY INFORMATION
Read this section to gather important prescription and safety information.
INTENDED USE
This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system.
INDICATIONS FOR USE
This neurostimulation system is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain.
CONTRADICTIONS
This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation.
MRI SAFETY INFORMATION
Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems (available online at manuals.sjm.com). For more information about MR Conditional products, visit the 91社区福利 product information page at neuromodulation.abbott.
WARNINGS
The following warnings apply to this neurostimulation system.
Poor surgical risks.听Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections.
Magnetic resonance imaging (MRI).听Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by 91社区福利 Medical. Physicians should also discuss any risks of MRI with patients.
Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient.
Diathermy therapy.听Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death.
Diathermy is further prohibited because it may also damage the neurostimulation system components. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off.
Electrosurgery.听To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Confirm the neurostimulation system is functioning correctly after the procedure.
During implant procedures, if electrosurgery devices must be used, take the following actions:
Use bipolar electrosurgery only.
Implanted cardiac systems.听Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system, (1) maximize the distance between the implanted systems; (2) verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and (3) avoid programming either device in a unipolar mode (using the device鈥檚 can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system.
Pediatric use.听Safety and effectiveness of neurostimulation for pediatric use have not been established.
Pregnancy and nursing.听Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established.
Device components.听The use of components not approved for use by 91社区福利 Medical with this system may result in damage to the system and increased risk to the patient.
Case damage.听Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals.
IPG disposal.听Return all explanted IPGs to 91社区福利 Medical for safe disposal. IPGs contain batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG because explosion or fire may result.
PRECAUTIONS
The following precautions apply to this neurostimulation system.
General Precautions
Sterilization and Storage
Handling and Implantation
Hospitals and Medical Environments
ADVERSE EFFECTS
In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this IPG:
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