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Edwards, Boston Sci Make TAVR Progress In Europe

 
• By Elizabeth Orr

Edwards Lifesciences' Sapien 3 transcatheter aortic heart valve is now labeled in Europe for use in patients who face an intermediate risk from open-heart surgery, matching a recent US development. Meanwhile, Boston Scientific's next-generation Lotus Edge TAVR device gained a CE mark.

Medical device giants Edwards Lifesciences Corp. and Boston Scientific Corp. have obtained new CE marks on their transcatheter aortic valve replacement (TAVR) products, the companies announced at the ongoing Paris Course of Revascularization (PCR) London Valves meeting in London.

Edwards’ Sapien 3 valve has been granted a CE mark to use the device in patients suffering from severe, symptomatic...

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Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By Marion Webb

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

More from Device Area

Aneira Health Launches New Precision Medicine Platform Exclusively For Women

 
• By Natasha Barrow

Cecilia Lindgren, Aneira Health’s co-founder and chief science officer, said that the company has “redesigned the diagnostic model.” The subscription-based platform offers clinical-grade and AI diagnostics alongside clinical consultation.

Ultrahuman Launches Home Health Monitoring

 
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HistoSonics’ Edison System Gains Limited UK Access, While Awaiting CE Marking

 
• By Shubham Singh

While HistoSonics is awaiting the CE mark in Europe, it hit a major milestone by securing early limited market access in Great Britain under a Unmet Clinical Need Authorization (UCNA), bringing its noninvasive histotripsy treatment to patients with liver tumors.