Cardiology Catheters News
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Neurescue`s Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arrest
COPENHAGEN, Denmark--(BUSINESS WIRE)--Neurescue, a medical device company developing innovative cardiovascular solutions to improve the outcomes for emergency patients, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market the company’s NEURESCUE® device for temporary occlusion of large vessels, including patients requiring emergency ...
By Neurescue
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How ReFlow Helped Get Zachary’s Hydrocephalus Under Control and Travel Across the Globe
Even before Zachary was born nearly 11 years ago, his parents Sherry and Jason knew that he was going to be a special boy – and a wonderful sibling to a twin sister! Zachary was born with spina bifida and hydrocephalus, both of which were diagnosed while in utero. As with many children in the hydrocephalus community, most parents have never heard of the condition, nor understand how it ...
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Anuncia Medical Announces the First Successful US Implant of the Company’s Newly Commercially Released ReFlow Mini Flusher Device for Hydrocephalus Patients
Intermountain Primary Children’s Hospital First in the Country to Implant this Next Generation FDA-Cleared Device Company Welcomes Vice President of Sales & Marketing, Mark Geiger, Who Lives with Hydrocephalus Anuncia Medical Inc. (“Anuncia” or the “Company”), a Company specializing in advancing innovations for implantable and external cerebrospinal fluid ...
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7-year-old Boy Managing His Hydrocephalus with ReFlow Ventricular System “Gen 1” Featured on Charleston’s ABC News 4
After struggling to conceive a child for what felt like ages, Miranda of Moncks County, South Carolina finally fell pregnant - a miracle that quickly turned into horror when she delivered at 24 weeks in late 2015. At just 1 pound and 12 ounces, her son, Sutton, arrived with life-threatening health issues, including hydrocephalus - a neurological disorder caused by an abnormal buildup of ...
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Anuncia Medical, Inc., receives FDA clearance for the ReFlow System Mini for the treatment of patients with hydrocephalus
Anuncia Medical, Inc., announced that the U.S. Food and Drug Administration (FDA) cleared the ReFlow® System Mini for the treatment of patients with hydrocephalus and other cerebrospinal fluid (CSF) disorders that require shunting. Anuncia Medical announced FDA clearance of ReFlow® System Mini for the treatment of cerebrospinal fluid (CSF) disorders. The FDA 510(k) clearance allows ...
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Imricor Submits for Approval to Commence VT Trial in Europe
Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR), the global leader in real-time iCMR cardiac ablation products, is pleased to announce that the Company has submitted for approval to commence a real-time iCMR-guided ventricular tachycardia (VT) ablation clinical trial. The name of the study is “Vision-MR Ablation of VT” or VISABL-VT. VISABL-VT is a prospective, ...
By Imricor
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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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Adagio Medical Announces Publication of Cryocure-2 Data Reporting 85% Freedom from AF at 12 Months After a Single Ablation Procedure in Patients with Persistent Atrial Fibrillation and Discusses Current Status of iCLAS Cryoablation System
Adagio Medical, Inc., a leading innovator in catheter ablation technologies for atrial fibrillation (AF) and ventricular tachycardia (VT), announced the publication of the results of its Cryocure-2 ultra-low temperature cryoablation (ULTC) study in patients with AF in the Journal of American College of Cardiology (JACC), Clinical Electrophysiology.1 The study prospectively enrolled 79 patients at ...
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Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch Ventricular Restoration System
Santa Clara, Calif.– July 12, 2022 – Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch® Ventricular Restoration System. Currently being evaluated in the CORCINCH-HF pivotal clinical trial, the AccuCinch System ...
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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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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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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 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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Acutus Medical completes enrollment in IDE trial with its AcQBlate FORCE Sensing Ablation System
Acutus Medical (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced successful completion of patient enrollment in the company’s AcQForce™ Flutter Investigational Device Exemption (IDE) clinical trial which enrolled 110 patients at 21 sites globally. The AcQForce Flutter trial was designed to ...
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Kardium’s Globe® System Begins Clinical Trial at St. Paul’s Hospital
VANCOUVER, British Columbia –?Kardium?Inc.?announces a successful first-in-BC investigational* clinical procedure using the Globe® Mapping and Ablation System. Dr. Marc Deyell of St. Paul’s Hospital leads the study using the Globe System to navigate inside the heart and diagnose where the rhythm disturbances occur. Once identified, the same device can then deliver immediate ...
By Kardium Inc.
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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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