The world of chronic pain is one that tends to lack subtlety. When a patient-a Marine no less-describes his day-to-day as, ”Any 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,” you know you are dealing with a cruelly heightened state of existence.
And when that same person describes his pain relief after implantation of Abbott's Proclaim™ XR SCS (spinal cord stimulation) as allowing him the opportunity to have the moments raising his two-year-old daughter that he thought he’d, “lost forever,” the stakes are clearly illuminated. Not just for this patient, but for the approximately 20% of all Americans who live with debilitating chronic pain.
But, while life-altering improvements can occur when Abbott’s neuromodulation devices are activated, these dramatic changes are far from the end of the story. As recently highlighted in CEO Robert Ford’s keynote address at the 2022 CES event, Abbott is focused on remaining a leader in medical technology, continually building on a vision that will enhance patient care.
A vital component of that vision is improving experiences for both patient and physician.
We’re on it. We are building a neuromodulation platform that offers ongoing improvement designed to continually upgrade products for our patients – past, present, and future. The focus is on enhancing patient care without having to replace implanted devices.
New Labeling Means New Opportunities
Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the ProclaimTM 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’s actually a pretty big 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, complex scans over 30 minutes will be faster due to reduced down time between scans.
Just ask Dr. Pankaj Mehta, Medical Director, Chief Medical Officer and Director of Research at Pain Specialists of 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 Abbott, 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
“I’m excited about this MRI compatibility announcement,” said Dr. Mehta. “Being 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’s a regular part of clinical care.
“These 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 separate out 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.”
Prior to this new FDA labelling, physicians wishing to use Abbott’s proprietary BurstDR™ technology were restricted in their lead placements with regard to MRI when using the Proclaim XR SCS. This limited the quality of the diagnostic images that could be taken of patients using the device. “It’s highly imperative that if you have therapy going on, that your device be MRI-compatible to have high-quality images,” said Dr. Mehta.
“Especially when treating people with multiple pain generators, we want to have current images to make the best therapeutic decisions,” said Dr. Mehta. “This new labeling allows for that.”
Getting Time on One’s Side
Another subtle, but extremely important, change in the labeling benefits the patient even more directly. Patients with the Proclaim XR SCS device need only 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. “It allows clinicians to get to the source of a particular issue in less time and without fear of compromising safety or creating complications,” said Dr. Timothy Deer, president and chief executive officer at The Spine and Nerve Centers of the Virginias.
According to Dr. Mehta, shorter down times between scans will greatly improve the experience for patients, some even more than others. “When 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’t be still for long periods of time, may be on anxiety meds or facing some other challenge. For veterans with PTSD, asked to be in loud, confined spaces, the longer they spend at the MRI facility, the worse it is for them.
“It’s a wonderful benefit to the patient to not have to spend hours at the MRI facility. Many times, because of someone’s 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 a CT experience with MRI-quality images. For those looking at, perhaps, several additional scans, this calming news is even more important.”
As valuable as these new advantages are to both patients and physicians in the present, they will continue to help out in the future, as care continues. “You get the excellent Abbott 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. “I think it’s a huge win for the patients in my practice.”
Fewer Pains. 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’s the subtle changes that illuminate that path:
- Higher quality diagnostics to help optimize the treatment plan and remove roadblocks to better health.
- Less-daunting MRI facility experiences which may be associated with physical and emotional trauma.
- Ever-improving care algorithms that make patient life easier while leaving the device intact.
- Knowing a team is always working to improve that device platform to make their lives easier, physically and emotionally.
Continuing on the path, confident that others are ahead, working to improve the journey.
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. 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 neurostimulation.