Axonics Modulation Technologies (NSDQ:AXNX) said today that it submitted an amendment to the FDA premarket approval application for its implantable r-SNM System 1 Sacral Neuromodulation device seeking full-body magnetic resonance imaging labeling. The amendment comes backed by complete test data which will support full body conditional labeling for 1.5 Tesla MR scanners, the Irvine, Calif.-based company […]
Neuromodulation/Neurostimulation
AtriCure launches CryoIce CryoSphere probe
AtriCure (NSDQ:ATRC) today launched its CryoIce CryoSphere probe in the U.S. The Mason, Ohio-based company’s CryoSphere probe is designed to block pain by temporarily ablating peripheral nerves. The device features a bendable distal shaft and an ergonomic handle that enables cardiac, thoracic and general surgeons to easily target peripheral nerves. ArtiCure’s CryoSphere technology uses a freezing […]
Swedish patient receives ‘dexterous, sentient’ prosthetic hand
A Swedish woman with a hand amputation has become the first recipient of an osseo-neuromuscular implant to control a dexterous hand prosthesis, according to Chalmers University of Technology in Gothenburg, Sweden. Surgeons placed titanium implants in the two forearm bones (radius and ulna), and extended electrodes to nerves and muscle to extract signals to control a […]
Could this device replace pacemaker batteries?
The heart’s motion is so powerful that it can recharge lifesaving cardiac devices, according to new research from Dartmouth College. Engineers at Dartmouth’s Thayer School of Engineering developed a dime-sized device to convert the heart’s kinetic energy into electricity to power a wide range of implantable devices, according to the Hanover, N.H.-based college. Get the full […]
Relievant back-pain device study stopped for positive results
Relievant Medsystems said it has halted enrollment in a clinical trial of its Intracept lower-back pain device due to the device’s superiority over non-surgical management. The Level I Intracept study found a “highly significant reduction” in the Oswestry Disability Index (ODI) score in patients treated with the Intracept procedure over patients in the non-surgical management arm. The […]
Boston Scientific launches Spectra WaveWriter SCS in Europe
Boston Scientific (NYSE:BSX) said today that it launched its Spectra WaveWriter spinal cord stimulator, intended for treating chronic pain, in Europe. The Marlborough, Mass.-based company said that its Spectra WaveWriter is designed to deliver electrical pulses of varying frequency, pulse width and amplitude to the spinal cord. Boston Scientific touted the device as the first and only […]
Pain-management firm SPR Therapeutics seeks to raise $20m
SPR Therapeutics has raised $8 million of a $20 million Series C round of funding that began Jan. 19, according to an SEC filing. The Cleveland-based company’s Sprint peripheral nerve stimulation (PNS) system is FDA-cleared for both chronic and acute pain, including post-operative and post-traumatic pain. The product was launched in November 2018 with indications […]
Abbott touts effective pain management, lower energy use in BurstDR SCS study results
Abbott (NYSE:ABT) late last week released results from a study of its BurstDR spinal cord stimulation technology, touting that it provided as effective pain relief as standard SCS despite providing lower-energy, intermittent stimulation known as “microdosing,” for patients with chronic intractable pain. Results from the BOLD study were presented at the 22nd Annual North American Neuromodulation […]
Stimwave touts 6 month MIS SCS trial results
Stimwave today touted six-month data from a trial of its minimally invasive spinal cord stimulator system. The company’s pivotal Surf trial compared a variety of waveform options without the need for separate trial devices. Stimwave reported that in the high and low frequency groups, back and leg pain responders were more than 92% and 86%, […]
Medtronic kicks off study for pain pump
Medtronic (NYSE:MDT) said today that it enrolled the first patient in a study to assess the use of its SynchroMed II intrathecal drug delivery system as an alternative to oral opioids. The 100-patient Embrace TDD study is slated to follow patients who have weaned off all oral opioids, in the hopes of positioning the SynchroMed II […]
Cala Health launches trial for Cala Two neurostim device for essential tremor
Cala Health last month launched a clinical trial of the latest version of its wearable neurostimulator for treating essential tremor, eyeing extended use of the wrist-worn device. The Burlingame, Calif.-based company won de novo clearance from the FDA last April for the Cala One device for transient relief in adults with essential tremor. The 500-patient, single-arm […]