CLINICAL TRIALS, STUDIES, REGISTRIES, DATA

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.

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.

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

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.

The study data indicates that by using a Bactiguard endotracheal tube the risk of this complication is significantly reduced", says Professor Pierre Damas.

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”.

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.

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.