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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
IMPRESSION Randomized Trial: Past the Halfway Mark and Progressing Rapidly
The sirolimus coated balloon thus seems to be a promising option as the Magic Touch - AVF was granted breakthrough device designation by FDA in 2019, and the IMPRESSION RCT will provide the much-needed data.
Early Feasibility Study Demonstrates Successful Use of Abiomed’s preCARDIA Technology
The study met the safety and feasibility endpoints and suggests for the first time that with the preCARDIA system it is possible to rapidly reduce cardiac filling pressures and augment urine output by intermittently occluding the superior vena cava in patients with ADHF
Patient Enrollment is Complete in the DOD-Funded Study of Extracorporeal Hemopurification of Critically Ill COVID-19 Patients
“We expect the first peer-reviewed PURIFY-OBS clinical trial publication soon, now that the study has concluded. We are pleased to see these consistent and very positive results and we’re pleased to know we have helped save the lives of many critically-ill COVID-19 patients,” said ExThera Medical CEO Robert Ward.
AtriAN Medical’s Clinical Data Update on the Neural AF Multi-center Study
Pioneering cardiac autonomic pulsed field ablation (PFA) technology provides a unique option for enhancing the durability of AF ablation.
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.