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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
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.
Positive Outcomes for iSTAR Medical’s MIGS MINIject
The final two-year data from the STAR-I trial and the six-month follow-up data from the STAR-II European trial, which are comprised in the pooled analysis, will both be presented at the upcoming European Society of Cataract and Refractive Surgery (ESCRS) meeting on October 2-4. The six-month primary endpoint results from the STAR-II trial of MINIject have recently been published in the peer-reviewed Journal of Glaucoma, the official publication of the World Glaucoma Association.
First-in-Human Implantation of Saturn Transcatheter Mitral Valve Reported Successful
The Trans-Apical TMVR procedure was performed as part of an on-going European clinical trial on August 19, 2020 at Santaros Klinikos University Hospital in Vilnius, Lithuania with the Heart Team of Kęstutis Ručinskas, MD, Audrius Aidietis MD, Vilius Janušauskas, MD, and Valdas Bilkis, MD supported by Paolo Denti, MD and Stefano Stella, MD.
Medtronic Reports the First Enrollments in the ALLEVIATE-HF Clinical Trial to Evaluate the Ability of Reveal LINQ Insertable Cardiac Monitor
The LINQ device will alert clinicians if a patient is at high risk for a heart failure event, allowing time for a physician to adjust medications to enhance patient health.
First Patient Enrollment in AAA-SHAPE Study – IMPEDE-FX Embolization Plug Devices Used for AAA Sac Filling During Elective EVAR Repair
The beginning of enrollment is a significant milestone for the Company as we continue to evaluate the potential of this novel application in aortic therapies.” The study will enroll up to 15 patients outside of the United States.