Aortic Valve News
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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 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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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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Terumo Aortic Announces US FDA Approval for Thoraflex Hybrid
Terumo Aortic today announced that the US Food and Drug Administration (FDA) has granted approval of the Thoraflex Hybrid Frozen Elephant Trunk (FET) device for commercial sale in the United States for the treatment of patients with complex aortic arch disease. Thoraflex Hybrid is the first of its kind device used in Frozen Elephant Trunk (FET) repair in the United States and was granted ...
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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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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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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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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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CytoSorbents Appoints Daniel Wendt, MD, PhD, MHBA, FECTS as Vice President, Medical Affairs Cardiovascular
CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, announces the appointment of Professor Daniel Wendt, MD, PhD, MHBA, FETCS as Vice President, Medical Affairs Cardiovascular commencing January 1, 2022. Dr. Wendt is an internationally renowned academic cardiac surgeon with over ...
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Saranas® Announces Initial Enrollment of Clinical Trial Assessing the Utility of Early Bleed Detection in Patients Undergoing Mechanical Circulatory Support
Saranas, Inc., has announced initiation and first patient enrollment in SAFE-MCS, a multi-center, single arm, open-label clinical trial evaluating the safety of complex high-risk percutaneous coronary intervention (PCI) using mechanical circulatory support (MCS) and surveillance with the Early Bird Bleed Monitoring System. The first patient was enrolled at Atlantic Health System’s ...
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Five TAVR Patients Successfully Implanted with DurAVR Valve
Anteris reports successfully implanting five TAVR patients during the week of 14 November 2021 in a first-in-human (FIH) study to assess the DurAVR THV system for treating severe aortic stenosis. The study was carried out at the Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia. The transcatheter aortic valve replacement procedures for all five patients were successful and without any ...
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DurAVR accepted into TCT innovation session
Anteris Technologies Ltd (ASX: AVR) (Anteris or the Company) announces its submission at this year’s Transcatheter Cardiovascular Therapeutics (TCT) conference at Orlando, Florida, United States was accepted into the innovation session. The TCT conference, running from November 4 to 6, is the largest and most prestigious Interventional cardiology meeting held each year and will return to ...
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JenaValve Announces First European Commercial Implants with the Trilogy™ Heart Valve System
JenaValve Technology, Inc., developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced the first commercial implants with the Trilogy Heart Valve System in Europe. The procedures, which included treatment of both aortic regurgitation1 (AR) and aortic stenosis1 (AS), took place in multiple centers in Germany, marks the official start of the ...
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CytoSorbents Announces Availability of Preliminary Data Abstracts from Two Endocarditis Studies, including the REMOVE study, to be Presented at the EACTS Conference
CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification, announced the public availability of preliminary data abstracts from two separate endocarditis studies, including the REMOVE study, to be presented at the upcoming European Association for Cardio-Thoracic Surgery (EACTS) annual meeting ...
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Berlin Heart Received CE Mark and Announces First Implantation of the Latest Cannula Generation to Treat Heart Patients Waiting for a Donor Heart
Berlin, September 2021: Berlin Heart today announces the CE mark and first implantation of an innovative outflow cannula for mechanical circulatory support with the paracorporeal pulsatile EXCOR® ventricular assist device. The EXCOR® Graft Cannula* connects the outflow side of the blood pump to the ascending aorta for left ventricular support or to the pulmonary artery for right ...
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Anteris appoints Chief Medical Officer
Anteris Technologies Ltd (ASX: AVR) (Anteris or the Company) announces the appointment of the internationally recognized Interventional Cardiologist, Dr Chris Meduri MD MPH, as its Chief Medical Officer (CMO). Dr Meduri is a recognized leader in the field of valvular heart disease, serving as the national principle investigator of several valve trials and on numerous steering committees. He has ...
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