The U.S. FDA approved the Proclaim XR spinal cord stimulation system by Abbott Laboratories for painful diabetic peripheral neuropathy (DPN). The system offers an alternative to patients for whom oral medications do not provide sufficient relief. About half of individuals with diabetes will eventually develop peripheral neuropathy which primarily damages the nerves running down the legs to the feet.
Seven new U.S. medtechs are poised to make a splash in the diagnosis and treatment of nervous system disorders thanks to funding under a new program within the National Institutes of Health (NIH) Blueprint for Neuroscience Research called Blueprint Medtech.
Onward Medical NV reported clinical outcomes for the first 10 patients given therapy to regulate blood pressure using its implantable ARC technology. This pulse generator produced an immediate improvement in blood pressure regulation in all study participants.
Building on the U.S. FDA approval of its Proclaim Plus spinal cord stimulation (SCS) system in August, Abbott Laboratories notched another approval with the FDA’s greenlight of the Eterna spinal cord stimulation system.
Leadinno Medical Valley Co. Ltd. reported it has raised more than ¥100 million (US$14.5 million) in a series A round for the development of its implantable electrical neurostimulation devices.
Valentine’s Day is a great day for creating that tingly feeling, but Abbott Park, Ill.-based Abbott Laboratories believes that this is not a good sensation for patients who are in search of pain relief via spinal cord stimulation (SCS) devices. Thus, the company touts its Proclaim Plus as a system that delivers a tightly titrated charge to multiple sites on the spinal cord to generate an analgesic effect without that tingling sensation, an outcome the company said is preferred by 87% of those in need of SCS for pain relief.
Patent litigation is notoriously drawn out in some instances, as is the case with disputes between Boston Scientific Corp. (BSX), of Natick, Mass., and Nevro Corp., of Redwood City, Calif. However, the two announced Aug. 1 that they have come to terms over several lawsuits, with each enjoying the right to practice some of the disputed patents and Nevro taking in a net payment of $85 million.
Saluda Medical Pty Ltd. raised $125 million in equity financing to commercialize and scale up its Evoke spinal cord simulation system for chronic pain and to advance its technology platform across an emerging portfolio of neuromodulation therapies.
Medtronic plc received FDA premarket approval Friday for use of its Intellis rechargeable and Vanta recharge-free neurostimulators in patients with diabetic peripheral neuropathy (DPN), suddenly tripling the number of spinal cord stimulators approved for the indication. Medtronic’s implantable spinal cord stimulators (SCS) now join Nevro Corp.’s HFX, which has had the distinction since July 2021 of being the only device with FDA approval for DPN, also known as painful diabetic neuropathy (PDN).
Medtronic plc released initial results showing meaningful pain relief using differential target multiplexed (DTM) spinal cord stimulation (SCS) endurance therapy, a lower-energy form of its DTM SCS treatment for overall, back or leg pain. At three months, patients in the on-label, prospective, multicenter study reported that their overall pain was about half what it was at the start of the study, measured by a 3.9 cm reduction on the 10 cm Visual Analog Scale (VAS) vs. 7.8 cm at baseline. Patients in the study also reported an average decrease in back and leg pain or 4.3 cm and 5.0 cm, respectively. Medtronic plans to offer the DTM SCS endurance therapy on its rechargeable Intellis and primary cell Vanta platforms.
