endovascular device News
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ASTM F2914 - 12 Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
The purpose of this guide is to provide a procedure for determining the appropriate attributes to evaluate in a shelf-life study for an endovascular device. 1. Scope 1.1 This guide addresses the determination of appropriate device attributes for testing as part of a shelf-life study for endovascular devices. Combination and ...
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Symple Surgical Announces Collaboration and Development Partnership with Global Medical Device Manufacturer
Flagstaff, Arizona – August 28, 2016 – Symple Surgical Inc. (“SSI”) announced today the signing of a development agreement with a confidential strategic partner whose long standing market leadership position in endovascular device therapies makes it an ideal partner to continue development of novel microwave ablation technologies. As part of this agreement both parties ...
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Saluda Medical Appoints Robert Palmisano to Board of Directors
Saluda Medical Pty Limited (“Saluda Medical”), a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced neural activation and sensing technologies designed to treat debilitating neurological disorders, today announced the appointment of Robert (Bob) Palmisano to its Board of Directors. “Bob’s ...
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SoundBite Medical Solutions Announces First Use of its Novel 0.014” Active Wire to Successfully Treat Calcified Below-The-Knee CTOs
Soundbite Medical Solutions Inc. (SBMS) announced today the first use of its novel Active Wire 0.014” platform in the successful treatment of patients suffering from critical limb ischemia (CLI) with heavily calcified below-the-knee (BTK) chronic total occlusions (CTO). The procedures were performed by Professor Marianne Brodmann, Head of the Clinical Division of Angiology, Department of ...
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Centerline Biomedical’s Intra-Operative Positioning System Technology Showcased at VIVA Disruptive Technologies Session
Centerline Biomedical, Inc. was one of eleven companies selected to present during the Disruptive Technology for Endovascular Therapy sessions during this year’s Vascular InterVentional Advances (VIVA) meeting. Company CTO Vikash Goel presented the Cleveland Clinic spinoff’s Intra-Operative Positioning System (IOPS) technology to an audience of vascular surgeons, interventional ...
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Cerus Endovascular Receives FDA Breakthrough Device Designation for its Contour Neurovascular System
Cerus Endovascular Ltd., a privately-held, commercial-stage medical device company, today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Contour Neurovascular System™. Breakthrough Device Designation is granted to medical devices and device-led combination products that provide the potential for a more effective ...
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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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