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Latest From Reed Miller
ACC Results Recap Part I: Low-Risk TAVR Trials Bring Good News For Edwards And Medtronic; Apple Watch Detects AFib In Apple Heart Study
Medtech Insight's Results Recap is a regular feature covering the major device trial results compiled by MedDeviceTracker. This is the first of two Results Recaps covering trial data presented at the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, including presentations on Medtronic and Edwards Lifesciences’ transcatheter aortic valves and Apple’s Apple Watch, which now has electrocardiography capabilities.
Global Device Approvals, Weekly Snapshot: FDA Approves Bard’s Venovo Stent; Abbott’s MitraClip Gets Indication-Expansion; Boston Scientific’s Watchman FLX Earns CE Mark
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved Bard’s Venovo venous stent system for symptomatic iliofemoral venous outflow obstruction, FDA added functional mitral regurgitation to the approved labeling for Abbott’s market-leading MitraClip, and Watchman FLX, Boston Scientific’s next-generation left-atrial appendage closer earned a CE Mark in Europe.
Starts & Stops: CardioFocus Studies HeartLight X3 In Persistent AF; IntraLink Spine Launches Trial Of Low-Back Device In Australia
Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from March 4 through March 17, including trial announcements from CardioFocus, Innovative Cardiovascular Solutions, IntraLink-Spine, Geneveve, Acutus, and Stereotaxis.
Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This is a special edition covering trial data presented during the first three days of the American Academy of Orthopedic Surgeons Annual Meeting, held in Las Vegas March 12-16, including presentations on devices from Stryker, Miach, Myoscience, CyMedica, and Reflexion Health.
The new indication covers functional mitral regurgitation, also known as secondary mitral regurgitation, which represents two-to-three times as many patients as the primary mitral regurgitation population MitraClip is already labeled for. The approval is supported by results from the COAPT trial, the first randomized trial to show that a mitral-valve repair could improve outcomes in patients with secondary mitral regurgitation.
Device Week, March 14, 2019 – Smith & Nephew Boosts Wound Care Biz; Key Cardiac Trial Results At March Meetings
In this edition of Device Week, Medtech Insight’s Catherine Longworth discusses Smith & Nephew’s $660m acquisition of regenerative medicine company Osiris Therapeutics. And Reed Miller talks about the clinical trial highlights from the recent CRT Meeting in Washington and looks forward to the American College of Cardiology conference next week.