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Clinical Trials

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Device Week, Sept. 13, 2018 – A Big Week For LivaNova; Creavo Seeks Cardiac Test Breakthrough

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.

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Latest From Clinical Trials

TCT 2018: Next-Gen Stents, Key Insights From Leading Experts

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.

Commercial Clinical Trials

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.

Starts & Stops Tracking Trials

TCT 2018: Abbott Expects COAPT Results To Support Expanding MitraClip's Indication

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.

Clinical Trials Innovation

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.

Tracking Trials Clinical Trials

Enforcing ClinicalTrials.Gov Reporting Requirements: FDA Issues Draft Guidance

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.

Clinical Trials Compliance

Results Recap: Sept. 7-13, 2018

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.

Tracking Trials Clinical Trials

NICE Endorses Sutureless Aortic Valves While LivaNova Reaches Study Milestone

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.

Clinical Trials Companies

Starts & Stops: Sept. 3-9, 2018

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.

Tracking Trials Starts & Stops

CMR Surgical Launches Robotic System To Rival Intuitive’s Da Vinci

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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