Cardiology FDA Approved Structural Heart

Endologix wins FDA approval for abdominal stent graft system

Released on March 16, 2020

Endologix today said it received FDA approval for its Alto Abdominal Stent Graft System. The company said it received approval based […]

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CE Mark Neuro Structural Heart

Rival to Boston Scientific device used in TAVR wins CE mark

Released on March 11, 2020

Dive Brief: Keystone Heart, a unit of China’s Venus Medtech, said Tuesday it received a CE mark for use of its […]

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Cardiology Structural Heart Surgery

CryoLife Wins EU CE Mark for E-vita Open NEO Hybrid Stent Graft

Released on March 6, 2020

CryoLife, Inc., a company based outside of Atlanta, Georgia, announced this week that it has received the European CE Mark for […]

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Cardiology Structural Heart

Cardiologist groups back Abbott push to change heart device coverage

Released on March 6, 2020

Dive Brief: Healthcare professionals have voiced support for Abbott’s request for CMS to stop using the terms bridge-to-transplant (BTT) and destination […]

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Cardiology CE Mark Structural Heart

CryoLife wins CE Mark for ascending aortic prosthesis

Released on March 2, 2020

CryoLife Inc. (NYSE:CRY) announced that it received CE Mark approval for the On-X ascending aortic prosthesis (AAP) for treating native or prosthetic heart valves […]

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Cardiology Pediatrics Structural Heart

Adjustable Heart Valves Grow with Kids Hearts

Released on February 27, 2020

A variety of congenital cardiac abnormalities require the placement of prosthetic heart valves in very young children. As the hearts grow, […]

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Cardiology FDA Cleared Structural Heart

Analysis casts doubt on Boston Scientific TAVR embolic protection device

Released on February 25, 2020

Dive Brief: A research letter and editorial published online Monday in JAMA Internal Medicine renews debate over whether embolic protection devices […]

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Cardiology FDA Approved Structural Heart

Cardiovalve scores FDA wins for its transcatheter tricuspid valve replacement tech

Released on February 21, 2020

Cardiovalve (Or Yehuda, Israel) said today that U.S. FDA has granted a breakthrough device designation for its transcatheter tricuspid valve replacement system. […]

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Cardiology M&A Structural Heart

Teleflex strikes $260M deal, gaining device used in TAVR procedures

Released on February 20, 2020

Dive Brief: Teleflex has struck a $260 million deal to buy IWG High Performance Conductors as it looks to build on […]

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Cardiology Structural Heart

This heart valve can adapt as a child grows

Released on February 19, 2020

Boston Children’s Hospital is touting a new design that could allow children to maintain the same prosthetic heart valve until adulthood, […]

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Cardiology MedTech Structural Heart

As CMS coverage decision nears, Abbott gears for MitraClip expansion

Released on February 18, 2020

Dive Brief: Awaiting a Medicare reimbursement decision any day for its MitraClip transcatheter mitral valve repair device, Abbott is expanding manufacturing […]

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Cardiology FDA Approved Structural Heart

8 types of FDA-approved devices that treat the heart

Released on February 14, 2020

Just starting to learn about all of the medical devices out there for treating cardiovascular diseases? The U.S. FDA has a […]

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