Abbott Laboratories had a winning week, scoring U.S. FDA approval of its Infinity directional deep brain stimulation (DBS) system in treating symptoms of Parkinson’s disease not adequately managed by medication. The company also reported new data underscoring the benefits of its Proclaim XR neuromodulation system in people living with chronic pain at the North American Neuromodulation Society (NANS) conference in Las Vegas.
The expanded indication allows Infinity DBS to target the internal globus pallidus (GPi), an area of the brain involved in regulating motor function, and makes it the only directional DBS system approved for all major targets in treating movement disorders, Parkinson’s and essential tremor, according to the company. In addition to GPi, those targets include the subthalamic nucleus and ventral intermediate nucleus.
Available in nearly 30 countries
The approval means Americans living with Parkinson’s disease now will have the same option for treatment as those in Europe. Infinity DBS received a CE mark for Parkinson’s, as well as tremor and dystonia, in January 2019. The system is currently available in close to 30 countries.
“The internal segment of the … GPi is a well-established, valuable DBS target for the management of the motor signs associated with Parkinson’s disease and is a preferred target for many patients, particularly those with troublesome medication-induced dyskinesia,” said Jerrold Vitek, head of the neurology department, director of the Neuromodulation Research Program and center director of the University of Minnesota Udall Center of Excellence for Parkinson’s Research. “This approval expands the options for patients to tailor treatment to their unique needs, with the added benefits of being able to target precise areas and utilizing a patient-friendly iOS device.”
The FDA based its decision on the interventional, nonrandomized, double-masked PROGRESS trial. The study has shown that “90.6% of study participants had a wider therapeutic window with directional stimulation compared with conventional stimulation, achieving the superiority endpoint (p<0.001),” Binith Cheeran, director of medical affairs for Abbott’s DBS business, told BioWorld. “In addition, a post hoc an analysis showed that directional stimulation allowed for a 35% reduction in the current strength required for meaningful benefit compared with conventional stimulation.”
Being able to use a lower current level could prove to be an added plus by extending the life of the recharge-free system, he said.
Infinity DBS operates on an iOS software platform with Bluetooth wireless technology. The software includes Informity programming, one of several upgrades the FDA approved in the summer of 2018 that allows doctors and patients to easily manage symptoms and changes.
BOLD and TRIUMPH studies
During NANS, Abbott reported new data from the prospective, multicenter BOLD study assessing the effectiveness of microdosing BurstDR stimulation in patients with chronic intractable back or leg pain. The FDA approved Abbott’s Proclaim XR neuromodulation system with BurstDR stimulation waveform in October 2019, based on the BOLD study. The recharge-free system uses low doses of mild electrical pulses to alter pain signals as they travel from the spinal cord to the brain, providing pain control for up to 10 years.
At the start of the study, 78% of patients had a baseline Oswestry Disability Index (ODI) score of severe, crippling or bed bound. After six months of treatment with Proclaim XR, just 29% of patients had severe or crippling pain, with 71% of patients experiencing only minimal to moderate pain.
Efficacy also was demonstrated in pain catastrophizing scale (PCS) scores, which fell by 62% with BurstDR. PCS is a patient-reported measure of how chronic pain affects a person’s sense of wellbeing.
Abbott also presented data from the prospective, global, single-arm TRIUMPH study showing significant improvement in physical, mental and emotional status up to one year following permanent implantation of Proclaim XR.
“We’re still only scratching the surface of what spinal cord stimulation can do in patients experiencing chronic pain,” said Keith Boettiger, vice president of Abbott’s neuromodulation business. “The more we learn and study the BurstDR stimulation waveform and low intermittent dose stimulation, the more we are able to apply this technology to real-world situations.”
Pushing the boundaries with the BRAIN initiative
Abbott has been generating a lot of excitement with its neuromodulation technology. Last year, the NIH partnered with the company via its BRAIN (Brain Research through Advancing Innovative Neurotechnologies) initiative that seeks to advance neuroscience research. While neuromodulation already has shown success in treating chronic pain and progressive movement disorders, the Abbott-NIH effort could open up new uses for existing technologies or novel ways of stimulating nerves.
Allen Burton, medical director of Abbott’s neuromodulation business, spoke enthusiastically about the NIH effort. “Since we announced our partnership in May of 2019, we’ve worked closely with this important institution on the BRAIN initiative for chronic pain and progressive movement disorders, like Parkinson’s disease,” he told BioWorld. “While the TRIUMPH study is not a direct result of our partnership, we’re looking forward to further discussing these data at the 6th Annual BRAIN Initiative investigators meeting in June.”
Cheeran added that Abbott has made its entire neuromodulation device portfolio available for studies under the BRAIN umbrella. “We are excited to push the boundaries of our knowledge using our innovative technology, from BurstDR to directional lead technology in DBS,” he said.
During the fourth quarter of 2019, Abbott’s neuromodulation revenue totaled $222 million, up 2% from the same period the prior year. The growth was spread across spinal cord stimulation, RF and DBS, Burton said. “As we continue to roll out Proclaim XR, we’re confident in the coming year and look forward to sharing insights about our neuromodulation portfolio as a whole.”