FDA approves Activa DBS system for Parkinsons of at least 4 years duration- Medtronic
Medtronic has announced FDA approval of Medtronic Deep Brain Stimulation (DBS) Therapy for use in people with Parkinson's disease of at least four years duration and with recent onset of motor complications, or motor complications of longer-standing duration that are not adequately controlled with medication. In 2002, the FDA initially approved Medtronic DBS Therapy for use in patients with advanced Parkinson's disease. Medtronic DBS has demonstrated improvement in motor complications, quality of life, activities of daily living and reduction in medication usage in individuals with Parkinson's disease.
This approval by the FDA was based on data from the EARLYSTIM clinical study, published in the New England Journal of Medicine in 2013, which found that patients treated with Medtronic DBS Therapy and best medical therapy (BMT) reported a mean improvement of 26 percent in their disease-related quality of life at two years, compared to a one percent decline in patients treated with BMT alone. In a study of patients with longer-standing motor complications, DBS patients' quality of life improved 20 percent from baseline to six months compared to no improvement in the patients treated with BMT alone.
Related news and insights
Medtronic plc announced three-month results from an on-label, prospective, multi-center study showing meaningful pain relief using DTM SCS endurance therapy, a modified, lower-energy variation of the company's Differential Target Multiplexed (DTM) Spinal Cord Stimulation (SCS) therapy for chronic overall, back or leg pain.
Pfizer Inc. announced that FDA approved Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.
Pfizer Inc. announced positive top-line results from a Phase III study (B7471026) describing the safety and immunogenicity of Prevnar 20 (Pneumococcal 20-valent Conjugate Vaccine) in 570 adults in the United States 65 years of age or older when administered at the same time as the Pfizer-BioNTech COVID-19 Vaccine or when each vaccine was given with placebo.