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HighLife Receives IDE Approval to Initiate US Pivotal Clinical Study for treatment of Mitral Regurgitation

DAIC

milla1cf Mon, 06/03/2024 - 12:36 June 3, 2024 — HighLife SAS , a medtech company focused on the development of a novel Trans-Septal Mitral Valve Replacement (“TSMVR”) system to treat patients suffering from moderate to severe Mitral Regurgitation (MR), announced today that the U.S. I am honored to lead the HighLife pivotal study.

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4C Medical's AltaValve System Secures Dual FDA Breakthrough Device Designations, Expediting Patient Access to Advanced Mitral Valve Therapies

DAIC

milla1cf Wed, 05/08/2024 - 11:02 May 8, 2024 — 4C Medical Technologies, Inc. ("4C 4C Medical"), a medical device company dedicated to advancing minimally invasive therapies for structural heart disease, has been granted Breakthrough Device designation by the U.S. If left untreated, MR can lead to heart failure or death.

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Henry Ford Health Heart Failure Patient First in Michigan to Receive Breakthrough Device

DAIC

Henry Ford Health's Center for Structural Heart Disease team delivered its first in Michigan FDA-approved VOQUE Transcatheter Tricuspid Valve Replacement System to a heart failure patient on February 13, 2024 at Henry Ford Hospital in Detroit. Other symptoms include swelling in the abdomen, legs or neck veins.

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Edwards Acquires JenaValve and Endotronix, Expands into Aortic Regurgitation and Heart Failure

CardiacWire

Edwards Lifesciences is going all-in on structural heart and heart failure, acquiring aortic valve-maker JenaValve Technology and implantable heart failure monitor company Endotronix for $1.2B and up to $445M in milestone payments.

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Canary Completes First-in-Human Trial of Cardiac Auscultation Monitoring Sensor

DAIC

The device is being developed as a first-in-class implantable sensor to provide daily adjunctive objective cardiac parameter measurements enabling patients and clinicians to better manage their congestive heart failure symptoms with current medication management tools. heart failure market is projected to be $70B annually by 2030.

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Edwards Lifesciences to Sell Critical Care to BD

DAIC

The sale enhances Edwards’ balance sheet flexibility for disciplined investments in technologies for aortic, mitral, tricuspid and pulmonic patients, as well as new therapeutic areas for interventional heart failure.

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BioCardia Announces United States Patent Issuance on Morph DNA Multi-Directional Steerable Catheter Transseptal Application

DAIC

The present invention relates to medical methods for transseptal access to the heart using steerable introducers based on the Company’s Morph DNA technology. This additional patent protection for BioCardia’s current and future products in this important existing market enhances shareholder value.