Abbott has announced the U.S. launch of the company's Proclaim DRG Neurostimulator System, a new device designed to deliver stimulation to the dorsal root ganglion (DRG) and alleviate pain in patients suffering from complex regional pain syndrome (CRPS) of the lower limbs. With the Proclaim DRG system, Abbott has added new, patient-centric benefits to a device capable of delivering the company's sustained and superior pain relief for patients battling CRPS.
Using Bluetooth wireless technology, iOS‡ software and a more intuitive Apple‡ iPod touch‡ mobile digital device as the system's controller, the Proclaim DRG system is designed to provide patients new benefits over traditional neurostimulation systems.
The Proclaim DRG platform is magnetic resonance (MR)-conditional and recharge-free, offering upgradeability and increased battery capacity over Abbott's previous generation systems.
"Both clinical and real world data have shown that DRG stimulation produces long-term, meaningful pain relief for patients with complex regional pain syndromes – like those resulting after total knee arthroplasty, foot surgery or hernia surgery," said Timothy Deer, M.D., an interventional pain physician, president and chief executive officer of the Spine and Nerve Center of the Virginias in Charleston, West Virginia, and co-principal investigator of the ACCURATE study.
"The ability to offer DRG stimulation on the Proclaim platform is a very exciting advancement for those of us who treat patients with these debilitating conditions and want to provide relief from hard-to-treat neuropathic conditions."
According to the National Pain Foundation, one in four people in the world suffers from chronic pain and the condition is a key driver of visits to physician offices and a reduction in quality of life.
CRPS is a type of chronic pain caused by a malfunction of the peripheral and central nervous systems due to injury, disease or trauma. The condition is one of the most difficult types of pain to treat because of its complexity in intensity and location.
Since Abbott's DRG therapy originally launched in the U.S. in 2016, adoption of the therapy has accelerated quickly and has been well received by patients in need of targeted stimulation that can address pain associated with CRPS. To date, implants have been performed by more than 540 physicians in all 50 states.
Patients who receive the Proclaim DRG system can undergo magnetic resonance imaging (MRI) in MRI scanners up to 1.5 Tesla and will not have to recharge their battery over the life of the device. Abbott has also made the Proclaim DRG system upgradeable and has increased the battery capacity over Abbott's previous generation systems.
To provide the most user-friendly experience, the Proclaim DRG Neurostimulator System also utilises an iPod touch‡ mobile digital device as the system's patient controller communicates wirelessly via Bluetooth wireless technology.
The first generation DRG system, known as the Axium Neurostimulator System, used a larger controller that did not have Bluetooth wireless technology.
The Proclaim DRG Neurostimulator System supports Abbott's focus on helping physicians manage patients with difficult-to-treat chronic pain in specific areas of the lower body, such as the foot, knee, hip or groin.
Clinical research, such as the ACCURATE study, has demonstrated that DRG stimulation can provide superior pain relief in patients with CRPS compared to traditional spinal cord stimulation therapy.
The study also found patients receiving DRG stimulation reported better therapeutic targeting and a reduction in paresthesia (the tingling feeling common to traditional SCS) compared to traditional tonic SCS.