Heart Valves News
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HTG Used for First Time in Congenital Heart Defect Surgery
It was another first for EchoPixel when its Holographic Therapy Guidance (HTG) was used in a congenital heart surgery at Cincinnati Children’s Hospital Medical Center. The procedure was conducted with a new mini 4D transesophageal echocardiography (TEE), which generates real-time ultrasound images and can be used in patients as small as 11 pounds. A life-saving procedure Complete ...
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1st MitraClip Procedure Guided by 4D Performed at UC Davis Health
Sacramento, CA – The first MitraClip procedure using EchoPixel’s Holographic Therapy Guidance (HTG) was performed by Structural Heart Physicians at UC Davis Health. The image acquisition was led by Edris Aman M.D. while the procedure was performed and HTG guidance utilized by Gagan Singh, M.D., director, Cardiovascular Research Unit. MitraClip is a procedure that approximates ...
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Confluent Medical Technologies Announces Grand Opening of Costa Rica Expansion
Confluent Medical Technologies (Confluent), today announced the Grand Opening of the latest addition to their large scale manufacturing center of excellence in Alajuela, Costa Rica expanding their capacity for Nitinol processing and catheter manufacturing. This new facility will be co-located with the existing Confluent Costa Rica facility and will add an additional 66,000 square feet to this ...
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SafeHeal appoints medical device industry veteran Chris Richardson as Chief Executive Officer
PARIS, France/Tampa, FL – July, 11, 2022 – SafeHeal™, a leading innovator in the field of digestive surgery and developer of the Colovac device, announced today the appointment of Chris Richardson as Chief Executive Officer (CEO), who assumes responsibilities immediately. Richardson has over 30 years of experience in the medical device industry, and an extensive ...
By SafeHeal
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iRhythm builds case for wearable cardiac monitor with data in fainting, TAVR patients
iRhythm Technologies has presented new data on its Zio wearable cardiac monitoring device at the American College of Cardiology (ACC) 71st Annual Scientific Session & Expo, building the clinical case for its devices. One study used Zio AT for monitoring patients who were taken to hospital after fainting. By using the device to monitor patients after discharge, the physicians reduced ...
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FDA Grants Saranas DeNovo Designation for the Early Bird® Bleed Monitoring System
Saranas Inc., a medical device company with innovative technology for real-time detection and monitoring of internal bleeding during endovascular procedures, today announced that it has been granted de novo classification by the U.S. Food and Drug Administration (FDA) for the Early Bird Bleed Monitoring System. According to a recent study of over 17,000 large-bore transcatheter interventions ...
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Saranas Recognized as One of Houston’s Most Innovative Companies
Saranas Inc., a medical device company pioneering technology for real-time detection and monitoring of internal bleeding during endovascular procedures, today announced that it has been named one of Houston’s most innovative companies. Saranas is the only medical device company to be honored at the inaugural Innovation Awards presentation sponsored by the Houston Business Journal on ...
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Saranas™ Announces Initial Clinical Cases with the Early Bird™ Bleed Monitoring System
Saranas Inc., a medical device company with innovative technology for real-time detection and monitoring of internal bleeding during endovascular procedures, announced that the first clinical cases with Early Bird Bleed Monitoring System were performed at Atlantic Health System’s Morristown Medical Center (Morristown, NJ). The cases varied across multiple interventions including ...
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Saranas Launches Early Bird® Bleed Monitoring System in the U.S.
Saranas, Inc. today announced the commercial launch of the Early Bird Bleed Monitoring System in the United States. The Early Bird is the first and only device for the monitoring and early detection of endovascular bleed complications through a novel application of bioimpedance sensors. Saranas will demonstrate the device in Booth 1755 at the Transcatheter Cardiovascular Therapeutics (TCT) ...
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Sonia Madigan of the Market Herald interviews CEO Wayne Paterson on the progress of Anteris Technologies
Anteris Technologies (AVR) pauses trading as it plans for an upcoming capital raise On Thursday, the company entered a trading halt, pausing shares until Monday, August 2 It is unknown how much the company is planning to raise or where the funds will be spent On the market, Anteris last traded at $8.59 per share Anteris Technologies (AVR) has paused trading as it plans for an upcoming ...
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InnovHeart appoints David Wilson as Chief Executive Officer
InnovHeart s.r.l. announced today the appointment of David James Wilson, an experienced healthcare and medical device executive as Chief Executive Officer of the company and executive member of the Board of Directors. Mr. Wilson’s career spans over 30 years and includes broad, global leadership expertise in business strategy and operations, R&D, commercial readiness and product ...
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Xeltis accelerating clinical trial program
Xeltis announced today that is planning to accelerate its clinical trial program for three restorative devices in parallel. CEO Eliane Schutte provided a sneak preview on Xeltis’ plans to an audience of investors and medtech companies at the Medtech and Diagnostics Forum organised by the investment bank Canaccord Genuity Capital Markets. Xeltis currently has three restorative devices in ...
By XELTIS BV
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atHeart Medical Receives FDA Approval for the Second Phase of the ASCENT ASD U.S. IDE Trial
atHeart Medical, a medical device company dedicated to establishing the new standard of care for closure of atrial septal defects (ASD), today announced it has received approval for the start of the second phase of its ASCENT ASD U.S. Investigational Device Exemption (IDE) pivotal trial. The prospective, single-arm study is evaluating the safety and efficacy of the reSept™ ASD Occluder, ...
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InnovHeart raises $55 million in Series C financing to further develop the Trans-septal Saturn Transcatheter Mitral Valve Replacement System
Milan, January 27, 2022 – InnovHeart s.r.l., a developer of novel Transcatheter Mitral Valve Replacement (TMVR) systems for the treatment of mitral valve disease, announces the closing of its Series C financing with granting an exclusive licensing agreement to Grand Pharmaceutical Group Limited, (Grand Pharma) for its proprietary Saturn device in Greater China. The transaction pulled in ...
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T,C&A Lab Declares Capability of Biomedical Materials Testing
Since the last few decades, biomedical materials have been extensively used in a lot of medical applications, such as tissue scaffolds, wound care, regenerative dentistry, bone graft, implantable devices and cosmetic surgery. Earlier this month, T,C&A Lab, a branch of Alfa Chemistry, announces to provide biomedical material testing service for customers worldwide who would like to ensure ...
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Anteris reports successful interim results for the first-in-human trial for DurAVR
Anteris Technologies Ltd (ASX: AVR) reports the first-in-human DurAVR™ THV study met or exceeded its interim study objectives. At the 30-day follow up point, the first five patients of the planned 10-patient study showed: All five subjects continued to do well with no reported adverse events (no death, stroke, myocardial infarction, reintervention). An average 86% improvement in mean ...
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Anteris Technologies` 30-day data from in-human heart valve trial yields promising results
Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF)'s Wayne Paterson tells Proactive about the 30-day follow-up data just in from the company’s flagship heart valve, currently being tested in humans for the first time. The valve solves the problem of younger and more active heart patients who need a valve that performs better and lasts longer, and Paterson says these latest clinical results ...
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JenaValve Announces Strategic Investment and Licensing Agreement with Peijia Medical Limited
JenaValve Technology, Inc. (“JenaValve” or the “Company”), developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced a strategic investment and exclusive technology licensing agreement with Peijia Medical Limited (HKEX: 9996) in China. Under the terms of the agreement, Peijia has made a cash and equity investment in ...
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BIOMODEX and Montreal Heart Institute Team Up to Develop 3D Printed Pulsatile Heart Models
BIOMODEX®, the leader in biorealistic haptic simulators for physician training and rehearsals, and the Montreal Heart Institute (MHI), a world-renowned, ultra-specialized cardiology center, announced they are partnering to develop a new cardiovascular training solution to help cardiologists rehearse and train for complex valve-in-valve procedures. The teams will collaborate to develop ...
By BIOMODEX
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Confluent Medical Announces Significant Strategic Investment From TPG
Confluent Medical Technologies (“Confluent”), a leading materials science, development and manufacturing partner to medical device manufacturers (“OEMs”), today announced that TPG Capital, the private equity platform of alternative asset management firm TPG, has agreed to make a majority investment in the company. TPG Capital joins existing investor Ampersand Capital ...
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