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Clinical Trials

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TCT 2019: Boston Scientific's Acurate Neo TAVR Misses Endpoint In SCOPE I

Boston Scientific is looking ahead to the next-generation Acurate neo2 valve after results of SCOPE I showed worse rates of kidney injury and severe aortic regurgitation in patients treated with the self-expanding Acurate neo valve than in patients treated with Edwards’ Sapien 3 valve.

Clinical Trials Research & Development Cardiovascular
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EU Or US First Choice For Launching Innovative Products? What You Really Need To Know

The tightening of the EU regulatory system will increase timelines for the availability of devices, especially novel, high-risk devices. But those who believe the US system will be quicker should not be so eager to jump to conclusions. Clinical data expert Sarah Sorrel explains why.

Medical Device Europe

Device Week, 4 October 2019 – Demant Group Recovers From Cyber-Attack; TCT Conference Highlights

In this week's podcast, senior reporter Catherine Longworth provides an update on how the Demant Group is recovering from a ransomware attack that forced the Danish hearing-aid manufacturer to shut down its IT systems, and deputy editor Reed Miller reviews the highlights of the clinical trial presentations at the recent Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.

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TCT 2019: EXCEL Shows Similar Five-Year Outcomes With PCI And Surgery In Left-Main Disease

Intervention with Abbott’s Xience everolimus-eluting stent yielded similar long-term results as bypass surgery in the EXCEL trial.

Clinical Trials Research & Development

TCT 2019: Abbott’s Portico TAVR Crosses Non-Inferiority Threshold

Abbott’s Portico transcatheter aortic valve performed well enough to meet the statistical criteria for non-inferiority to surgery in the PORTICO IDE trial. The company will likely look to its next-generation of Portico for more impressive results.

Clinical Trials Research & Development

TCT 2019: One-Year PARTNER 3 Outcomes Show Better Quality Of Life With TAVR

An analysis of the PARTNER 3 trial shows transcatheter aortic replacement with Edwards Sapien 3 yields better health status outcomes than surgical valve replacement after one year.

Clinical Trials Research & Development

TCT 2019: TRILUMINATE Six-Month Results Support Abbott’s TriClip

The six-month results of the TRILUMINATE Feasibility trial support the safety and effectiveness of Abbott’s TriClip, a version of the company’s successful MitraClip adapted to repair the tricuspid valve. The company is now sponsoring a pivotal trial to support FDA approval of TriClip.

Clinical Trials Research & Development

TCT 2019: Five-Year PARTNER 2A Results Support TAVR In Most Intermediate Risk Patients

A new update from the PARTNER 2A trial shows transcatheter aortic valve replacement with Edwards Lifesciences' Sapien XT yields similar outcomes to valve surgery in intermediate risk patients.

Clinical Trials Research & Development

TCT 2019: BD, VIVA Data Show Lower Paclitaxel Mortality Risk

BD said an independent Lutonix review found no significant link to deaths, while further meta-analysis from trade group VIVA showed a decline in the risk.  Both studies were unveiled at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.

Cardiology Clinical Trials

TCT 2019: New COAPT Results Support, Durability And Cost-Effectiveness Of Abbott’s MitraClip

The three-year results from the COAPT trial confirm Abbott’s MitraClip transcatheter mitral valve replacement device can improve the prognosis of functional heart failure patients. A separate analysis of COAPT showed MitraClip is cost-effective compared to medical therapy.

Clinical Trials Research & Development
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