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In this edition of the Device Week podcast, Medtech Insight’s Reed Miller talks about the latest good news for LivaNova and Catherine Longworth provides an update on Creavo Medical, a UK-based company using an old technology for a new kind of cardiac test that could save hospitals money.
Latest From Clinical Trials
The Transcatheter Cardiovascular Therapeutics meeting held in San Diego featured late-breaking trials of new stent technologiesincluding TALENT, BIONYX, BIOFLOW-V, SORT-OUT IX, LEADERS FREE II and ReCre8.
Starts & Stops: MedAutonomic Initiates Phoenix Neuromodulation Stomach Implant Trial; Boston Scientific Completes S-ICD Trial Enrollment
Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made Sept. 17 through Sept. 23, including trial announcements from Boston Scientific, MedAutonomic, Desiral, and Edwards Lifesciences.
Data presented at the Transcatheter Cardiovascular Therapeutics conference Sept. 23 in San Diego will support expanding the label of Abbott's MitraClip mitral valve repair device to include secondary, or functional, mitral regurgitation, a company executive tells Medtech Insight. In the COAPT trial, MitraClip reduced the two-year rate of heart-failure hospitalization and all-cause mortality in patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation.
Results Recap: Terumo PulseCath Shows Promise In High-Risk PCI; Reapplix' LeucoPatch Promotes Ulcer-Healing
Results Recap is Medtech Insight's exclusive summary of clinical trial results that have been announced or published in the past week, based on information collected by Meddevicetracker. This week's edition covers the week of Sept. 14-20, including trial announcements from Nanobiotix, Reapplix, Profound Medical, Sequana Medical, and Terumo.
A new US FDA draft guidance describes the agency's plans to identify trial sponsors that have failed to submit required clinical trial registration and/or results information to ClinicalTrials.gov. The draft guidance also clarifies when the agency will seek civil money penalties for non-compliance, the applicable procedures for assessing civil money penalties and the civil money penalty amounts that may be assessed.
Results Recap is a new regular feature in Medtech Insight providing a summary of clinical trial results that have been announced or published in the past week, based on information collected by Meddevicetracker. This week's edition includes trial announcements from NeuroMetrix, Vertos, LivaNova, and Boston Scientific.
A new guidance from the UK's National Institute for Health and Care Excellence (NICE) concludes that sutureless aortic valve replacement is an alternative to conventional surgical aortic valve replacement. The NICE guidance came as LivaNova announced completed enrollment in the 900-patient, randomized PERSIST-AVR trial of its Perceval sutureless aortic valv.
Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made Sept. 3 through Sept. 9, including trial announcements from Nexstim PLC, PathMaker Neurosystems, Proven Process Medical Devices, and Edwards Lifesciences.
UK-based CMR Surgical has debuted its new portable robotic system Versius. "Inspired by the human arm,” it is expected to assist in surgeries on European patients beginning next year. Versius is set to rival Intuitive Surgical’s da Vinci robot systems, the current market leader in robotic surgery.
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