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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Agili-C Implant Receives FDA Breakthrough Device Designation: 251 Subjects Enrolled In IDE Clinical Study at 26 Sites in US, Europe and Israel
The company is currently conducting a pivotal IDE clinical study which is designed to evaluate the Agili-C™ implant superiority over the current surgical standard of care – microfracture and debridement.
PRISTINE Study with SELUTION SLR Sirolimus Drug Eluting Balloon: First Two Patients Enrolled
The PRISTINE registry is a follow up to the encouraging results seen in the PRESTIGE clinical trial (Below The Knee, Chronic Limb Threatening Ischemia) at 6 months.
Neuromod Devices Publish Positive Results from Large Scale Tinnitus Clinical Trial
Neuromod notes the clinical trial was conducted between 2016 and 2019 and was designed to track changes in tinnitus symptom severity. The trial investigated the bimodal neuromodulation approach, using Neuromod’s non-invasive stimulation device that delivers sound to the ears and electrical stimulation to the tongue.
Cardiovascular Systems Announces Presentation of Data From Large Coronary Orbital Atherectomy Study at the TCT Connect 2020 Conference
This is a large retrospective observational study from a high volume, tertiary center treating complex severely calcified de novo coronary lesions that underwent lesion preparation with OAS before stent deployment.
First Patient Implanted in ELITE Study of InterStim Micro System
The Evaluation of InterStim Micro System Performance and Safety (ELITE) study will enroll 160 subjects across 40 sites in the United States (and territories), Europe, Australia and Canada. Endpoints include patient-reported outcomes, disease-specific quality of life questionnaires, and symptom diaries. Patients will be followed for two years.
HistoSonics Announces Approval of its #HOPE4LIVER US Clinical Study
The study is a multi-center, open-label, and single-arm trial to evaluate the safety and efficacy in destroying liver tumors and will build upon the company's first-in-man THERESA Study recently conducted in Barcelona, Spain.
NuVasive’s MaXcess Retractor Published Study in the Journal of Neurosurgery: Spine Further Validates Prone, Single-Position Lateral Interbody Fusion
Prone positioning for a lateral approach presents an exciting opportunity for streamlining surgical access to the lumbar spine and facilitating a more efficient surgical solution with potential clinical and economic advantages for certain patients.
Radiometer: The UK Based Company Announces POCT Analyzers Help Tackle ED Overcrowding with a Faster Diagnoses
The study, authored by Clare Bailey, Divisional Director of Healthcare Professionals, Cancer and Clinical Support at Barking, Havering, and Redbridge University Hospitals NHS Trust, shows how Radiometer’s POCT ABL90 FLEX PLUS blood gas analyzers and AQT90 FLEX immunoassay analyzers have enabled the ED team to manage increasing patient numbers and deliver high-quality care.
New Data Presented at CIRSE for the Use of NEUWAVE System with Ablation Confirmation Software
NEUWAVE Microwave Ablation System is a minimally invasive technology that uses heat transmitted through image-guided needle-like probes to destroy targeted soft tissue lesions in the liver, kidneys and lungs.