The US Food and Drug Administration (FDA) has approved the Algovita Spinal Cord Stimulation System (Greatbatch Inc), a device to treat chronic pain, the company announced in a press release.
The device 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 failed back surgery syndrome, intractable low back pain, and leg pain.
Greatbatch also announced that it is in the process of finalizing the proposed spin-off of QiG Group, LLC, which will be renamed Nuvectra Corporation. Since its inception in 2008, QiG Group has developed an innovative, broad-based, neurostimulation technology platform, the company notes in a statement.
Initially, the company will focus on the commercialization of the Algovita SCS system, it said.
The proposed Nuvectra spin-off is expected to be completed in the first quarter of 2016, subject to the Form 10 registration statement becoming effective, the company noted.
The new stimulator joins other implanted stimulators for chronic pain. In May of this year, the FDA approved the Senza spinal cord stimulation (SCS) system (Senza System, Nevro) to aid in the management of chronic intractable pain of the trunk and/or limbs, which also includes pain associated with failed back surgery syndrome, low back pain, and leg pain.
This system delivers a high-frequency output of 10 kHz that does not cause paresthesia (a tingling sensation) in patients, said William Maisel, MD, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, in an FDA press release.
“Since some patients don’t like the paresthesia associated with traditional SCS, this device offers another treatment option.”
The FDA approved another stimulator, the Precision Spinal Cord Stimulator System (Advanced Bionics Corporation ), in 2004.
Although not approved in the United States, another device, the Axium Neurostimulator System, is called by the company (Spinal Modulation, which was acquired by St. Jude Medical) the “next- generation” intraspinal neuomodulation therapy. It targets the dorsal root ganglion (DRG) to provide a new pain management option.
According to the company’s website, the investigational product “has shown promising results in managing chronic intractable leg pain, as well as difficult-to-target anatomy such as the back and foot.”
By stimulating the DRG, therapy can be adjusted to cover either broad or specific areas of pain throughout the torso and legs while limiting uncomfortable postural effects typically experienced with other spinal cord stimulators, said the company. It believes that the device addresses shortcomings of current chronic pain management approaches.