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Topic: Structural Heart

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Cardiology Structural Heart Surgery

Study questions TAVR access disparities under new CMS coverage policy

Dive Brief: Rural hospitals were less likely to be eligible to start a transcatheter aortic […]

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Cardiology FDA Approved Structural Heart

Endologix wins FDA approval for abdominal stent graft system

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

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CE Mark Neuro Structural Heart

Rival to Boston Scientific device used in TAVR wins CE mark

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

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Cardiology Structural Heart Surgery

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

CryoLife, Inc., a company based outside of Atlanta, Georgia, announced this week that it has […]

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Cardiology Structural Heart

Cardiologist groups back Abbott push to change heart device coverage

Dive Brief: Healthcare professionals have voiced support for Abbott’s request for CMS to stop using […]

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Cardiology CE Mark Structural Heart

CryoLife wins CE Mark for ascending aortic prosthesis

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

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Cardiology Pediatrics Structural Heart

Adjustable Heart Valves Grow with Kids Hearts

A variety of congenital cardiac abnormalities require the placement of prosthetic heart valves in very […]

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Cardiology FDA Cleared Structural Heart

Analysis casts doubt on Boston Scientific TAVR embolic protection device

Dive Brief: A research letter and editorial published online Monday in JAMA Internal Medicine renews […]

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Cardiology FDA Approved Structural Heart

Cardiovalve scores FDA wins for its transcatheter tricuspid valve replacement tech

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

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Cardiology M&A Structural Heart

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

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

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Cardiology Structural Heart

This heart valve can adapt as a child grows

Boston Children’s Hospital is touting a new design that could allow children to maintain the […]

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Cardiology MedTech Structural Heart

As CMS coverage decision nears, Abbott gears for MitraClip expansion

Dive Brief: Awaiting a Medicare reimbursement decision any day for its MitraClip transcatheter mitral valve […]

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Cardiology FDA Approved Structural Heart

8 types of FDA-approved devices that treat the heart

Just starting to learn about all of the medical devices out there for treating cardiovascular […]

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Cardiology Funding Structural Heart

JenaValve raises $50m for TAVR tech

JenaValve Technology announced that it raised $50 million in equity financing as it develops and manufactures […]

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Cardiology MedTech Structural Heart

TAVR developer JenaValve nets $50M from Bain Capital Life Sciences

Heart valve maker JenaValve Technology has raised $50 million in new venture capital funding, not […]

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Cardiology FDA Implantables Structural Heart Vascular

Aria CV wins breakthrough nod for pulmonary arterial hypertension device

Aria CV announced that it won FDA breakthrough device designation for its pulmonary hypertension (PH) system […]

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Cardiology Structural Heart

BioVentrix Scores ‘High Priority’ Reimbursement in Germany

BioVentrix has received the renewal of the highest priority reimbursement in Germany for its transcatheter […]

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Cardiology FDA Structural Heart

Abbott wins FDA breakthrough nod for ventricular assist system

Abbott (NYSE:ABT) announced today that it won FDA breakthrough device designation for its in-development fully implantable […]

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Cardiology FDA Approved Structural Heart

Abbott Wins Approval for CATALYST Trial for At-Risk Stroke Patients

Lately, it seems as if Abbott Laboratories has been extremely busy building its structural heart […]

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Cardiology Structural Heart

MIT engineers have created a bionic ‘heart’

  Massachusetts Institute of Technology announced that engineers at the institute, along with others elsewhere, […]

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Cardiology Structural Heart

Edwards saw US TAVR procedures spike 40% in Q4

Dive Brief: Edwards Lifesciences’ nearly 20% year-over-year revenue growth topped Wall Street’s fourth quarter revenue […]

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Cardiology CE Mark Structural Heart

Abbott’s Tendyne First Transcatheter Mitral Valve to Win EU Clearance

Abbott just announced that it is the first company to receive European regulatory approval to […]

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Cardiology Structural Heart Surgery

Edwards study shows TAVR outcomes similar to surgery after 5 years, but with more patient management

A five-year study by Edwards Lifesciences demonstrated no significant differences in the number of deaths […]

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Cardiology Structural Heart

Abbott wins 1st EU approval for transcatheter mitral valve replacement device

Dive Brief: Abbott said Thursday it won the first EU approval for a transcatheter mitral […]

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Cardiology Structural Heart Surgery

5-year Edwards results: TAVR matches surgery on survival, but repeat hospitalizations more common

Dive Brief: Five years after undergoing aortic valve replacement, intermediate-risk patients who received an Edwards […]

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Cardiology Structural Heart

Edwards Lifesciences stock takes a hit on TAVR report

Edwards Lifesciences (NYSE:EW) shares are recovering a bit today — a day after the stock took […]

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Cardiology MedTech Structural Heart

Moody's predicts cardiology tech to outpace rest of medical devices, driven by TAVR

Dive Brief: Moody’s Investors Service expects revenues from cardiology technologies to outperform the wider medtech […]

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Cardiology FDA Structural Heart

Teleflex wins FDA clearance for Wattson temporary pacing guidewire

Teleflex (NYSE:TFX) announced today that it won FDA 510(k) clearance for its Wattson temporary pacing guidewire […]

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Cardiology Structural Heart

Abbott ups 2020 growth targets, downplays Libre 2 delay

Dive Brief: Longtime Abbott CEO Miles White’s final earnings call (the “85th or 86th” of […]

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Cardiology Structural Heart

Venus Medtech Announces the Addition of Two Cardiovascular Experts to Their Advisory Team

The leading transcatheter heart valve medical device player in China – Venus Medtech (Hangzhou) Inc. (“Venus Medtech” or the […]

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Robotics Structural Heart Surgery

Robotic Mitral Valve Repair May Offer Benefit for Many Patients

Mayo uses the Da Vinci surgical robot to perform minimally invasive mitral valve surgeries to intervene earlier […]

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Cardiology Structural Heart

Study of Abbott's HeartMate 3 points to single treatment indication for LVADs

Dive Brief: A study published in JAMA Cardiology on Wednesday​ of Abbott’s left ventricular assist device (LVAD) […]

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Cardiology Neuro Oncology Structural Heart

Amid Q4 letdown, Boston Scientific aims for $1B mark in structural heart

After reporting a fourth-quarter revenue shortfall due to a slowdown in its cardiac rhythm management […]

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Cardiology FDA Approved Structural Heart

Abbott to Initiate Trial to Study MitraClip as an Option for Moderate Surgical Risk Patients

ABBOTT PARK, Ill., Jan. 13, 2020 /PRNewswire/ — Abbott (NYSE: ABT) today announced that the U.S. Food and Drug […]

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Cardiology Structural Heart

JenaValve TAVR wins FDA breakthrough device designation

JenaValve Technology said today that FDA has granted breakthrough device designation for its JenaValve Pericardial TAVR. […]

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Cardiology MedTech Structural Heart

Miles White’s fearless strategy for growing Abbott

With strong leadership and a taste for risk-taking, outgoing CEO Miles White left no stone […]

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FDA Structural Heart

Does JenaValve’s New Designation Signal the Start of Another Strong Year for TAVR?

JenaValve is showing significant progress in the plan to get its transcatheter aortic valve replacement […]

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Cardiology Funding Structural Heart

Neovasc closes $10m direct offering

Neovasc (NSDQ:NVCN) announced that has it closed its previously announced registered direct offering for aggregate gross […]

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Cardiology FDA Approved Structural Heart

Abbott LVAD wins FDA approval for implantation without open heart surgery

Abbott (NYSE:ABT) today announced that FDA has approved implantation of its HeartMate 3 LVAD via lateral […]

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Original post by MedTech Dive

Written by: Susan Kelly

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