FDA Approves ARC-EX Device For Non-Invasive Spinal Cord Stimulation
Meanwhile, synthetic gel aids in recovery after spinal surgery; Pittsburgh researchers create helper robots for people with ALS; a study finds nerve stimulation is effective against treatment-resistant depression; and more.
Stat:
Onward Medical Spinal Cord Stimulator Gets FDA Nod
Spinal cord injuries dramatically reduce a person’s mobility and independence, but a new device could aid rehabilitation efforts. Onward Medical received Food and Drug Administration clearance on Thursday for its non-invasive spinal cord stimulator, the ARC-EX. In a recent trial, the stimulator boosted hand sensation and strength in 72% of participants. While the treatment cannot replace rehabilitative therapy, device users rave about its effects. (Broderick, 12/19)
WUFT:
A Slimy Surgical Method Could Someday Spell Relief For Spine Patients
For those recovering from spinal surgery, the process can be lengthy and precarious, as patients try to circumvent infection and regain mobility. A key hiccup? The ever-present risk of a herniated disc. Now, Swedish researchers may have identified an unlikely solution in the form of a slime, inspired by the slick coating that covers parasites in the stomach of cows. This slimy coating helps the parasites duck the immune system and prevents immune cells from recognizing them. (Hagmajer, 12/19)
CBS News:
Pitt Researchers Advancing Robot For People Living With ALS
A University of Pittsburgh research group is reaching new limits and perfecting a robot to help people with ALS live better lives. Stretch, a robot by the company Hello Robot, looks like a Roomba from the future. Researchers in Pitt's Accessible Smart-Tech Research Group teamed up with Hello Robot and the ALS Association to work on advancing Stretch. (Guay, 12/19)
CNN:
Vagus Nerve Stimulation May Relieve Treatment-Resistant Depression, Study Finds
Nick Fournie was 24 years old when severe depression upended his life. Fournie had been married to his longtime sweetheart for two years, and had no reason to suspect he had any mental health issues. “I just thought to myself, ‘If this is it, if this is all there is to life — if it ended now, I’d be OK with it,’” Nick, now 62 and based in Illinois, said of that fateful day outdoors nearly 40 years ago. (Rogers, 12/19)
Also —
MedPage Today:
FDA Approves Mesenchymal Stromal Cell Therapy For Refractory Acute GVHD In Kids
Reaching the end of a long road to approval, the first mesenchymal stromal cell (MSC) therapy for steroid-refractory acute graft-versus-host disease (GVHD) finally reached the FDA green light. The approval of remestemcel-L (Ryoncil) specifies use in pediatric patients 2 months or older with steroid-refractory acute GVHD. The cellular therapy received a vote of confidence from the Oncologic Drugs Advisory Committee in 2020, despite questions regarding the product's consistency and the approval request's reliance on data from a single-arm clinical trial. (Bankhead, 12/19)
MedPage Today:
For IBD, No Cardiovascular Risk Difference Between JAK, TNF Inhibitors
Major cardiovascular event risk in patients with inflammatory bowel disease (IBD) was no greater with Janus kinase (JAK) inhibitors than with tumor necrosis factor (TNF) inhibitors, according to a retrospective single-center study. ... Despite the effectiveness of JAK inhibitors for IBD, the authors noted that concerns about cardiovascular safety have circulated since the 2022 ORAL Surveillance study found a higher risk of major adverse cardiovascular events in rheumatoid arthritis (RA) patients who took tofacitinib compared with those on TNF inhibitors. (Haelle, 12/19)
CIDRAP:
Preventive Levofloxacin Found To Reduce Drug-Resistant TB In Household Contacts
Two studies published yesterday in the New England Journal of Medicine show that 6 months of preventive treatment with levofloxacin in children and adults with household exposure to multidrug-resistant tuberculosis (TB) resulted in statistically non-significant reductions in TB incidence compared with placebo. But an additional analysis of individual data from the two trials, which were conducted in Vietnam and South Africa, found that preventive levofloxacin led to a much larger relative reduction in cumulative incidence of TB than was initially observed. (Dall, 12/19)
