Medical company Boston Scientific Corporation (NYSE:BSX) reported on Monday the receipt of approval from the US Food and Drug Administration (FDA) for its ImageReady MRI labeling for the Vercise Gevia Deep Brain Stimulation (DBS) System for a full-body magnetic resonance imaging (MRI) environment to treat the symptoms of Parkinson's Disease (PD).
An estimated ten million people worldwide are affected by Parkinson's disease, causing symptoms of shaking or tremors, muscle stiffness, and slowness of movement.
The company added that the Vercise Gevia Deep Brain Stimulation system, along with the Vercise Cartesia Directional Lead, is designed to treat the symptoms of Parkinson's Disease (PD) by delivering precisely targeted electrical stimulation in the brain to provide optimal symptom relief and better control of unwanted side effects.
Following the US FDA approval, the patients can undergo a full-body MRI while benefiting from the latest advances in DBS therapy including directional stimulation and a longer-lasting rechargeable battery. The DBS therapy helps patients with Parkinson's disease control their symptoms and improve their quality of life.
Based on the clinical evidence from the company's INTREPID study, the patients treated with the Vercise System sustained a 48% improvement in motor function as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) III scores over two years.
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Precision Epigenomics partners with TruDiagnostic
Illumina's GRAIL divestment plan receives EC approval
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Ondine Biomedical's Steriwave approved for use by HCA UK
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial
Syros receives Fast Track Designation from FDA for tamibarotene in AML
Ligand Pharmaceuticals announces presentation of Captisol-enabled Topiramate Injection data