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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Restrospective Study Finds That Masimo SET® Pulse Oximetry Has No Difference in Accuracy or Bias Between Black People and White People
By comparison to the Masimo finding of 0.15% difference in bias between black and white subjects, the 2020 letter to the editor reported a difference in bias of 8.1% in a cohort of black and white hospital patients2 – 54 times higher than the Masimo result.
SynerFuse Proof-of-Concept Study-1st Patient Implanted in Integrated Spinal Fusion & DRG Neuromodulation
The study involves combining spinal fusion with the implant of a neurostimulator to provide stimulation of the DRG, a key nerve structure along the spine that can be targeted with neuromodulation to treat chronic neuropathic pain.
Robocath Concludes 1st European R-Evolution Clinical Study
The study was aimed at assessing the safety and efficacy of the R-OneTM robotic assistance platform. Sixty-two patients across six European hospital centers participated
Breakthrough in Device Therapy for Patients with Late Stage Heart Disease
The trial was conducted at the internationally recognised Centre of Excellence at the Catholic University of Leuven, in Belgium. The success of this ground-breaking study marks a further step in the integration of the two companies who are committed to taking this life changing innovation in partnership to patients across the globe.
Published VITAL Study on Bactiguard’s Endotracheal Tube
The study data indicates that by using a Bactiguard endotracheal tube the risk of this complication is significantly reduced", says Professor Pierre Damas.
Leman Micro Devices: World-first Clinical Trial Update
Dr. K. Saumya, Principal Investigator for the trial, said “This device will be a real life-saver in India. It is small and affordable and will alert people to the need to consult a doctor about their blood pressure before they have symptoms and before it gives rise to awful consequences such as stroke, kidney damage, heart attack or blindness”.
HeartPoint Global Announces Successful Pre-Clinical Trial of New Implant System
“It is encouraging to see that our Implant System has seen significant results in pre-clinical testing, especially as we prepare for our first clinical trials,” said Seth Bogner, Chairman & CEO of HeartPoint Global.
Neovasc Enrolls First Patient in COSIRA-II Trial for Neovasc Reducer; Up 1.6%
The results of this study will complement existing international safety and effectiveness data and support a pre-market approval application (PMA) to the U.S. Food and Drug Administration (“FDA”) for approval of the Reducer device in the United States.
Adagio Medical Announces Successful First-In-Human Cases of Pulsed Field Cryoablation for Treatment of Atrial Fibrillation
The patient, a 32-year-old man with paroxysmal AF and a 60-year-old man with persistent AF underwent successful pulmonary vein and posterior wall isolation using a dedicated PFCA catheter powered by the proprietary Adagio iCLAS™ cryoablation and pulsed-field ablation (PFA) consoles.