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Clinical Trials

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AHA 2019: French Registry Data Favor Edwards’ Sapien TAVR Over Medtronic’s CoreValve

Registry data from France shows transcatheter aortic valve replacement patients have better outcomes with Edwards’ Sapien balloon-expandable valves than with Medtronic’s CoreValve self-expanding valves.

Clinical Trials Research & Development Cardiovascular

Latest From Clinical Trials

FDA Gives Sponsors A New Tool To Prove MRI-Compatibility

The US FDA has qualified a new modeling tool that could give sponsors more assurance that their products meet the agency’s expectations for MRI-compatibility.

Regulation Review Pathway

QUOTED. 11 December 2019. Tejas Patel.

Corindus Vascular Robotics Inc. expects its CorPath GRX robotic intervention system will eventually be part of a widespread system of "telerobotic" intervention sites operated by specialists located far away. See what Tejas Patel, an interventional cardiologist at the Apex Heart Institute in Ahmedabad, India, said about it here.

Quoted Innovation

Corindus Envisions Network Of CorPath Robots For Remote Neurovascular And Coronary Interventions

The physician who led the first-in-human robotic-assisted neurovascular intervention with Corindus’ CorPath GRX system believes the technology could revolutionize neurovascular intervention by allowing a centralized interventional team to remotely treat patients.

Innovation Clinical Trials

R&D Roundup, November 2019: LimFlow Starts Pivotal Trial Of Peripheral Shunt; Conservative Coronary Treatment Matches Intervention In Trial

An overview of November’s 10 most-read Medtech Insight articles on topics related to research and development of new medical technology.

Research & Development Clinical Trials

RSNA 2019: AI, Machine Learning Continue To Dominate Developments In Radiology

Artificial intelligence (AI) and machine learning took center stage at this year’s Radiological Society of North America meeting in Chicago, and the pervasiveness of AI tech in new product launches was further emphasized at the RSNA’s expanded AI Showcase exhibit.

Artificial Intelligence Diagnostic Imaging

Global Approvals Snapshot: November 2019

November’s approvals include the US FDA approval of Medtronic’s In.Pact AV paclitaxel-coated balloon, for the treatment of arteriovenous access in patients with end-stage renal disease, and a CE mark that expands the indication for Edwards’ Sapien 3 TAVR device to include patients at low-risk during surgery.

Approvals Clinical Trials

Device Week, 29 November 2019 – Top Clinical Trial News From AHA & Investment Forecast From Jefferies 2019

In this week's Medtech Insight podcast, deputy editor Reed Miller discusses clinical trial news from the annual American Heart Association (AHA) meeting, and senior reporter Catherine Longworth highlights goings-on at the Jefferies Healthcare Conference in London.

Device Week Clinical Trials

QUOTED. 27 November 2019. Dan Rose.

LimFlow expects the US Food and Drug Administration to approve its percutaneous deep vein arterialization system for patients with advanced critical limb ischemia by the end of 2021. See what Lim Flow's CEO, Dan Rose, said about it here.

Quoted Innovation

LimFlow On Target For 2021 US Launch Of Deep Vein Arterialization System

The results from the PROMISE I feasibility study give LimFlow confidence that the PROMISE II pivotal trial will prove that the LimFlow percutaneous deep vein arterialization system is a safe and effective alternative to amputation for patients with critical limb ischemia.

Clinical Trials Business Strategies
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