IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative treatments for aortic disorders, announced today that it has received Investigational Device Exemption (“IDE”) approval from the United States Food and Drug Administration (“FDA”) to commence a new pivotal study to evaluate the safety and effectiveness of the Nellix […]
Peripheral/Endo
Cardiovascular Systems, Inc. Acquires Gardia Medical Ltd.’s WIRION™ Embolic Protection System
ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that it has acquired the WIRION Embolic Protection System and related assets from Gardia Medical Ltd., a wholly owned Israeli […]
Vascular Graft Solutions Announces CE Mark Approval for FRAME FR External Support for AV Fistula Repair
TEL AVIV, Israel, Aug. 5, 2019 /PRNewswire/ — VGS – Vascular Graft Solutions Ltd. announced today it has received CE Mark Approval for the FRAME FR, a novel solution for repair and stabilization of high flow and aneurysmal arteriovenous fistulas in hemodialysis patients. Although AV fistula is the preferred access for hemodialysis, up to […]
Teleflex Announces Publication of “Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device”
WAYNE, Pa., Aug. 01, 2019 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX) today announced the publication of the “Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device.” The SAFE MANTA IDE Clinical Trial, the largest U.S. prospective multi-center study of a purpose-designed large […]
Reflow Medical Enrolls First Patients in DEEPER OUS Spur Stent Trial
San Clemente, Calif., July 30th, 2019–(BUSINESS WIRE) —Reflow Medical, Inc. announces that the first patients have been enrolled in its DEEPER OUS clinical trial using the Temporary Spur Stent System. DEEPER OUS is a 100-patient prospective, non-randomized, multicenter trial designed to assess the safety and efficacy of the Temporary Spur Stent […]
Avinger Announces Pantheris SV Limited Launch and Successful Treatment of First Patients in the United States
REDWOOD CITY, Calif., July 29, 2019 (GLOBE NEWSWIRE) — Avinger, Inc. (Nasdaq: AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced that physicians in four U.S. sites have successfully treated several patients with […]
Medtronic Launches the VenaSeal Closure System in India to Treat Patients With Chronic Venous Diseases
Newly Approved Minimally Invasive Therapy Treats Diseased Veins Using Proprietary Medical Adhesive Mumbai, Maharashtra, India: India Medtronic Private Limited, wholly owned subsidiary of Medtronic plc (NYSE: MDT), today announced the launch of the VenaSeal™ Closure System, which is a minimally invasive procedure that uses a proprietary medical adhesive to close the diseased vein […]
First U.S. Patient Receives GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL
FLAGSTAFF, Ariz.–(BUSINESS WIRE)–W. L. Gore & Associates, Inc. (Gore) announces the first U.S. implant of the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System. The successful procedure was performed by William Jordan, M.D., chief of the Division of Vascular Surgery and Bradley Leshnower, M.D., cardiothoracic surgeon, at the Emory […]
Micro Medical Solutions Receives FDA IDE Approval for Pivotal Clinical Trial of MicroStent
WILMINGTON, Mass., June 24, 2019 /PRNewswire/ — Micro Medical Solutions (MMS), an innovator in the field of microvascular interventions that improve clinical outcomes and quality of life, announced today that it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). IDE approval allows MMS to initiate […]
BD Statement on FDA Circulatory System Devices Panel Regarding Paclitaxel-Coated Devices
FRANKLIN LAKES, N.J., June 20, 2019 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued the following statement following the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting related to the potential increase in mortality associated with […]
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