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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Sound Stimulation in Hearing Aids Shows Positive Effects for Tinnitus Treatment and Overall Well-Being
“Widex SoundRelax is the latest evolution in our evidence-based approach to tinnitus treatment, which leverages patented fractal tones algorithmically generated within Widex hearing aids. First introduced for tinnitus patients through Widex Zen tones, we’ve expanded the tone choices and included new modulated wave-like sounds, offering more options to help all wearers, with or without tinnitus, combat stress and sustain health,” said Dana Helmink, Senior Director of Audiology and Clinical Education at Widex USA.
Cook Medical Treats First Patient in First-in-human Clinical Trial for Venous Valve
The patient was treated by Dr. Mauricio Alviar, vascular surgeon and principal investigator, of Clinica de la Costa in Barranquilla, Colombia.
Research Study on Comfort of the New FLUME Catheter to Begin Recruitment
The FLUME catheter, which received clearance in November 2021 from the U.S. Food and Drug Administration (FDA), is designed to address some of the triggers that can negatively impact patients’ comfort and quality of life.
New Exactech Knee Research Demonstrates Ability to Achieve Balanced Results with Short Learning Curve Using Newton™ Technology
Exactech Knee notes the new study, which reviewed the first 273 surgeries using Exactech’s Newton Knee balancing system, demonstrated the ability of surgeons to achieve targeted gap balance throughout each patient’s range of motion.
10-Year Data from the Medtronic ENGAGE OUS Registry is the First and Only Prospective, Industry Sponsored Global EVAR Registry to Demonstrate a Decade of...
The ENGAGE OUS registry evaluated more than 1,200 patients. The 10-year data, which included follow-up from approximately 400 of these patients, showed a 94.7 percent freedom from aneurysm-related mortality (ARM) † and 64.1 percent sac regression (or decreased AAA sac diameter) ‡ at 10 years.
Nevro Announces Enrollment of First Patient in PDN Sensory Study
The PDN Sensory Study will enroll up to 236 patients at multiple sites across the U.S. Patients will be randomized to conventional medical management or 10 kHz Therapy™ plus conventional medical management, with optional crossover to the other treatment arm at 6 months if those criteria are met.
Know Labs Demonstrates Accuracy of Non-Invasive, Bio-RFID Technology with Ground-Breaking Proof-of-Principle Study
“Proof-of-principle studies are critical in demonstrating Bio-RFID accuracy for non-invasive methods of medical diagnostics. This was an essential step toward achieving our goal of delivering the first FDA-cleared, truly non-invasive glucose monitoring device to the market,” said Ron Erickson, CEO and Chairman at Know Labs.
Watkins-Conti Completes Stress Urinary Incontinence Yōni.Fit Device Trial
Seventy one (71) participants enrolled in a randomized, controlled, single-blind, multi-center study of the Yōni.Fit device in women with stress urinary incontinence.
NICO Corporation’s ENRICH Trial Evaluating Minimally Invasive Parafascicular Surgery (MIPS) for Intracerebral Hemorrhage (ICH) to be Presented at the 2023 AANS Annual Scientific Meeting...
The ENRICH trial results were accepted as a late-breaker and will be presented on Saturday, April 22 during an oral plenary session beginning at 8:30 a.m. PT (11:30 a.m. ET) by co-lead ENRICH investigator, Gustavo Pradilla, M.D., associate professor of neurosurgery at Emory University School of Medicine and chief of neurosurgery at Grady Memorial Hospital.