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