Relievant Medsystems announced today that three-year data from two clinical trials further validate its Intracept procedure. Intracept, a minimally invasive, FDA-cleared, same-day, outpatient procedure, treats chronic vertebrogenic low back pain. It uses targeted radiofrequency energy to ablate the basivertebral nerve (BVN), stopping it from transmitting pain signals to the brain. The procedure takes approximately one […]
Pain Management
Medtronic warns on potential cardioversion damage with some Vanta neurostimulators
Medtronic (NYSE:MDT) issued an urgent field safety notice in Europe to warn of potential issues with its Vanta implantable neurostimulator (INS). The letter communicated mitigations to reduce the risk of damage to the Model 977006 Vanta from a cardioversion procedure. It was dated June 2023. Medtronic said a cardioversion procedure may damage the electronics in […]
FDA approves Abbott spinal cord stimulation devices for non-surgical back pain
Abbott (NYSE:ABT) announced today that it received FDA approval for the use of its spinal cord stimulation devices (SCS) for certain people with back pain. The FDA approval applies to the treatment of chronic back pain in those who have not had or are not eligible to receive back surgery. This is also known as […]
FDA approves expanded label for Abbott Eterna spinal cord stimulation tech
Abbott (NYSE:ABT) announced today that the FDA approved expanded MRI labeling for its Eterna spinal cord stimulation (SCS) system. The expanded labeling includes new leads that are MR (magnetic resonance) conditional. It means people with chronic pain can undergo MRI scans within approved, outlined conditions with a wider selection of lead options for full-body scans. […]
NeuroOne launches Evo sEEG electrodes in the U.S.
NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it commercially launched its Evo sEEG electrode line in the U.S. Zimmer Biomet holds exclusive worldwide distribution rights to the Evo Cortical and sEEG product lines. NeuroOne expects the line to utilize Zimmer Biomet’s Rosa One Brain robotic surgery platform for neurosurgical procedures. Zimmer paid $3.5 million to […]
Nevro enrolls first patient in PDN Sensory study
Nevro this week announced it enrolled the first patient in its painful diabetic neuropathy (PDN) sensory study. The prospective randomized controlled trial will assess the restoration of neurological function as a primary objective in patients with intractable PDN. It will enroll up to 236 patients at multiple sites across the U.S. Patients in the trial […]
FDA approves spinal cord stimulation system from Biotronik
Biotronik announced today that it received FDA approval for its Prospera spinal cord stimulation (SCS) system. The regulatory nod marks the launch of the Lake Oswego, Oregon-based company’s new Biotronik Neuro business segment. Propsera features Resonance, a multiphase stimulation paradigm. It pairs with Embrace One, a patient-centric care model that provides automatic, objective, daily remote […]
NeuroOne completes animal implant of thin film lead for spinal cord stimulation
NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it completed an initial animal implant of its novel thin film paddle leads. These leads enable spinal cord stimulation (SCS). NeuroOne intends for the devices to treat patients with chronic back pain due to multiple failed back surgery syndrome, intractable low back pain and leg pain. Eden Prairie, […]
DOJ charges former Stimwave CEO over alleged non-functioning neuromod implant
The U.S. Justice Dept. (DOJ) announced today that it filed a two-count indictment charging former Stimwave CEO Laura Perryman, claiming a scheme around the company’s neuromodulation technology. Damian Williams, the United States Attorney for the Southern District of New York, Michael J. Driscoll, the Assistant Director in Charge of the New York Field Office of […]
Nevro fully launches HFX iQ spinal cord stimulation
Nevro (NYSE:NVRO) announced today that it initiated the full U.S. market launch for its HFX iQ spinal cord stimulation (SCS) system. Redwood City, California–based Nevro designed HFX iQ for treating chronic pain. The company commenced its full launch after it completed a successful limited market release. In a news release, Dr. Usman Latif called HFX […]
Axogen appoints Jens Schroeder Kemp as chief marketing officer
Axogen today announced it appointed Jens Schroeder Kemp as chief marketing officer. Kemp has more than 20 years of strategic marketing, sales and business development experience in the medical device industry. He will report directly to CEO and President Karen Zaderej. “I am thrilled to welcome Jens to Axogen. His extensive strategic marketing experience and […]