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Starts & Stops: FDA Approves Medtronic's Plan For 340-Patient Renal Denervation Trial

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from Nov. 5 through Nov. 11, including trial announcements from Medtronic, Evaheart, and VentureMed.

Starts & Stops Clinical Trials Innovation
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Results Recap: Long-Term Results Support NovoCure's Optune Brain-Cancer Technology

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, covering the week of Nov. 30 – Dec. 6, includes results of a retrospective post-hoc sub-group analysis of the EF-14 phase III pivotal trial of Novocare's Optune system in newly diagnosed glioblastoma, one-year data from a study of Vieve Medical's Geneveve treatment of mild-to-moderate stress urinary incontinence, and complete results from the Long-Term Treatment Study of NeuroPace's RNS system to treat epileptic seizures.

Tracking Trials Clinical Trials

FDA Device Panel Delivers Thumbs Up For Breakthrough Heart-Failure Device

A US FDA panel overwhelmingly supported a heart-failure device designed to use cardiac contractility modulation to improve heart function. The Optimizer Smart system from Impulse Dynamics is apparently the first in FDA’s Breakthrough Devices program to go before an advisory panel.

Advisory Committees FDA

US FDA Hopes ClinGen Database Will Spur Next-Gen Sequencing Products

The agency says it has evaluated ClinGen and will accept evidence based on the US National Institutes of Health-funded database for product applications. It hopes the use of the database will spur development of targeted treatments and diagnostics such as next generation sequencing tests.

Personalized Medicine In Vitro Diagnostics

Global Device Approvals, Weekly Snapshot: New Shoulder Component, AAA Graft

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. Newly added devices include a new LimaCorporate should component, US approval of the Incraft aneurysm stent graft and a first-in-class newborn-screening diagnostic.

Approvals Research & Development

Results Recap: Five-year CoreValve Results Support Durability Of TAVR

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, covering the week of Nov. 23 - Nov. 29, includes five-year data from the CoreValve US Pivotal Trial, the longest-term follow-up data from a randomized trial of Medtronic's CoreValve TAVR system, show it remains durable with low rates of severe hemodynamic structural valve deterioration compared to surgical valves. Also, results of a 2,800-patient study sponsored by Propeller Health, shows use of rescue-inhaler increased significantly along with increases in daily fine particulate matter exposure.

Tracking Trials Clinical Trials

Device Week, Nov. 30, 2018 – Bioprinting Is Moving From Far-Fetched To Reality; ‘Femtech’ Investment Heats Up

In this edition of Device Week, Medtech Insight managing editor Marion Webb discusses the ongoing research that could lead to 3D-printing of human replacement organs and reporter Catherine Longworth highlights the developments in “femtech,” medical technology primarily or exclusively for female patients.

Device Week Innovation

QUOTED. Nov. 21, 2018. Boyle Cheng.

The Center for Surgical Arts in Pittsburgh is amassing big-ticket medical devices to train residents and fellows in a variety of surgical specialties. See what Allegheny Health Network's Boyle Cheng said about the Center here.

Quoted Research & Development

Market Intel: Cornea, Bio-Drugs, Artificial Hips On Track For 3D Printing

Although certainly not a given, many researchers and companies are pursing the eventual goal of bioprinting human organs, starting with the three-dimensional printing of a structure that has cellular function. If organ function via bioprinting becomes a reality for the skin, bone, lung, liver, eye and/or kidney, among other potential organs, the market opportunity could be in the billions. But challenges, including cost and ethics, stand in the way of this milestone in regenerative medicine.

Regenerative Medicine Market Intelligence

'Where Technology Meets Science': Doctors, Medical Students Take Experimental Medtech For A Spin In Pittsburgh's Center For Surgical Arts

Some big-name device-makers – Medtronic, Stryker, Karl Storz, Siemens and more – are donating expensive capital equipment to the Center for Surgical Arts, a modern teaching lab that boasts 21 bays for training residents and fellows in various types of surgery. The companies are doing this to not only nail down future customers, but to test new devices, as well. The Center also includes a Bose test frame that was used to help clear Alphatec Spine's Solus device with US FDA without a clinical trial. "Those can be multimillion-dollar studies. So, to be able to do that, and to have the FDA feel comfortable with that, is kind of a cool capability," says Dr. Donald Whiting, chair of the Allegheny Health Network Neuroscience Institute.

Research & Development Innovation
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