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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Attune Medical Major Milestones: Including ensoETM in Cardiac Ablation Procedures Published Study and $4 Mil Convertible Note Closing
Dr. Mark Gallagher (St. George’s University Hospital, London UK) evaluated the use of the ensoETM in cardiac ablation procedures to ascertain whether using the esophageal space for temperature management could have the potential to decrease collateral thermal injury related to radio-frequency (RF) ablation for the treatment of atrial fibrillation.
Balt STEM Trial: First Patients Enrolled
The company recently announced that the first patients have been enrolled in the clinical trial; The SquidTM Trial for the Embolization of the Middle meningeal artery (STEM) for the treatment of chronic subdural hematoma [NCT04410146].
W. L. Gore & Associates Announces Six-Month Results With Biosynthetic Tissue Valve
W. L. Gore & Associates notes the six-month data for 16 patients enrolled across three sites in the United States were presented in a moderated poster session during the American Heart Association Virtual Scientific Sessions from November 13-17, 2020. The poster, P148, is titled, Early Results of a Novel ePTFE-based Pulmonary Valved Conduit in a Pediatric Patient Population.
SODAQ and Nordic Complete a Successful Pilot with a Covid-19 Corona Vaccine Temperature Tracker
November 26, 2020
SODAQ completed 50 successful runs tracking the location and temperature threshold of vaccine shipment containers from va-Q-tec by using the Nordic Semiconductor NRF91 communication...
ISABELLA Trial with SELUTION SLR 018 DEB Patient Trial Update: Successful Recruitment of 40 Hemodialysis Patients
ISABELLA Trial (Intervention with SELUTION SLR Agent Balloon for Endovascular Latent Limus therapy for failing AV Fistulas) s a prospective single-center, multi-investigator, non-blinded, single arm trial investigating the safety and feasibility of SELUTION SLR 018 DEB for the treatment of failing AV fistulas in 40 hemodialysis patients.
Research Paper Showing ProtoKinetix AAGP® Enhanced Stem Cell Derived Retina Precursor Cells Restoration of Vision
ProtoKinetix notes the research paper has been submitted to a prestigious journal specializing in tissue regeneration for peer review and editing.
NST002 Phase IIa Study (ALS) Promising Results Continue Reports NeuroSense
The study is set to be completed in January of 2021, following 12-months dosing.
One-Year Outcomes Data from the OptiMesh SCOUT Published
“We have found this innovative, minimally invasive device to be a safe and effective option for lumbar interbody fusion procedures,” said SCOUT lead investigator John Chi, M.D., M.P.H. Dr. Chi is the Director of Neurosurgical Oncology at Brigham and Women’s Hospital in Boston, Massachusetts, and Associate Professor of Neurosurgery at Harvard Medical School, and the author of the SPINE article.
Medtronic Cryoablation is a Superior Treatment Option for Symptomatic Paroxysmal Atrial Fibrillation Compared to Drug Therapy: Published in New England Journal of Medicine
"The clinical results of STOP AF First demonstrate the superiority of Medtronic cryoablation as a first-line treatment for AF patients, before the disease progresses," said Dr. Oussama Wazni, principal investigator for the STOP AF First trial and section head of electrophysiology at the Cleveland Clinic.