catheter tip News
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Kardium performs first cases with the Globe® Positioning System
VANCOUVER, British Columbia – Kardium is pleased to announce the first clinical use of the Globe Positioning System (GPS™) – the new 3D mapping and navigation feature of its flagship product, the Globe® Mapping and Ablation System. The Globe System is the most complete solution for the treatment of atrial fibrillation (AF) – the world’s most common heart rhythm ...
By Kardium Inc.
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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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Galaxy Medical Enrolls First Patients in SPACE-AF Study SAN
SAN CARLOS, California, September 20, 2021 — Galaxy Medical announced today the initiation of the SPACE-AF study with enrollment of the first two patients at Southlake Regional Health Centre in Newmarket, Canada. In the study, the CENTAURI Pulsed Electric Field (PEF) ablation system will be used to ablate both the pulmonary veins and posterior walls in patients with persistent atrial ...
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Imperative Care Announces First Patient Enrolled in the Imperative Trial Evaluating the Zoom 88 Large Distal Platform for the Treatment of Ischemic Stroke
Imperative Care, Inc. announced today that the first patient has been enrolled in the Imperative Trial. This prospective, multi-center clinical trial is the first study designed to evaluate the clinical benefits of direct aspiration for the treatment of ischemic stroke with the Zoom 88 Large Distal Platform, which is currently FDA cleared for neurovascular access. Additionally, the trial will ...
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FARAPULSE’s Pivotal ADVENT Trial underway with First Patients Treated with its Breakthrough Pulsed Field Ablation System to Treat Atrial Fibrillation
FARAPULSE Inc. today announced the first patients were treated in the ADVENT Trial, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial to evaluate the safety and effectiveness of its Pulsed Field Ablation (PFA) system for the treatment of paroxysmal Atrial Fibrillation (AF). AF is a heart rhythm disorder that affects nearly 6 million Americans and makes ...
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New Technology Leads to Decreased Hemolysis Rates
Laboratories in an increasing number of U. S. hospitals and healthcare systems are seeing significantly lower hemolysis rates in the blood specimens their staff are collecting with new technology designed for drawing blood with a single-use, sterile device that advances into the vein through a peripheral IV (PIV). The technology, PIVO (Velano Vascular, San Francisco, California), is ...
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Acutus Medical Initiates CE Mark Study for Focal Pulsed Field Ablation Therapy to Treat Atrial Fibrillation
Acutus Medical, Inc. (Nasdaq: AFIB) (“Acutus”), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the initiation of AcQForce PFA-CE, a new clinical study that will evaluate the safety and performance of the company’s focal force sensing Pulsed Field Ablation (PFA) catheter and system in combination with ...
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Imperative Care Announces U.S. Clearance of the ZOOM Aspiration System
Imperative Care, Inc., a company singularly dedicated to answering unsolved problems in stroke, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ZOOM™ Aspiration System – a family of products designed to facilitate clot removal during ischemic stroke. The ZOOM Aspiration System includes the ZOOM Reperfusion Catheters, ZOOM Aspiration ...
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An Easy, Predictable, and Simpler Way to Embolize Tumors
Instylla is now enrolling patients in a clinical trial for the world’s first hydrogel-based liquid embolic intended for the treatment of hypervascular tumors. A second initial application for its Embrace embolic therapy is hemorrhage control, where the product offers advantages in terms of simplicity, speed, and safety. Amar Sawhney and his teams, it seems, can make medical hydrogels do ...
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