TEL AVIV, Israel, Dec. 18, 2018 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced the publication of a meta-analysis of four clinical studies involving dual layered and […]
Peripheral/Endo
Hancock Jaffe Receives Approval for First-in-Human VenoValve Study
IRVINE, Calif., Dec. 17, 2018 (GLOBE NEWSWIRE) — Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI, HJLIW), a company specializing in medical devices that restore cardiac and vascular health, announced today that it has received regulatory approval from INVIMA, the Colombian equivalent of the U.S. Food and Drug Administration, for its first-in-human […]
Aortica Corp. Announces FDA Approves Medtronic Valiant NAVION™ for Inclusion in Starnes’ Physician-Sponsored IDE
BELLEVUE, Wash.–(BUSINESS WIRE)–Aortica Corporation today announced that FDA has approved a supplement to an ongoing Physician Sponsored IDE study at the University of Washington (UW) sponsored by Principal Investigator & Chief of Vascular Surgery Dr. Benjamin Starnes. The positive decision allows the use of Medtronic’s Valiant NAVION™ stent graft system […]
Endologix Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq: ELGX) (the “Company”), a developer and marketer of innovative treatments for aortic disorders, announced today the grant of inducement equity awards to three newly hired employees (together, the “Awardees”). The awards were approved by the Company’s Compensation Committee, which is comprised of independent Directors, on December 5, […]
Otsuka Medical Devices and Veryan Medical Announce Completion of Acquisition
TOKYO, Japan and HORSHAM, U.K., 13 December, 2018 — Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), a 100% subsidiary of Otsuka Holdings Co., Ltd., and Veryan Medical Ltd. (“Veryan”) announce the completion of the acquisition of Veryan by Otsuka Medical Devices through its UK subsidiary Otsuka Medical Devices UK […]
Shockwave Announces collaboration With Abiomed on Physician Training
SANTA CLARA, Calif., Dec. 11, 2018 (GLOBE NEWSWIRE) — Shockwave Medical, a pioneer in the development and commercialization of intravascular lithotripsy to treat complex calcified cardiovascular disease, today announced an investment and collaboration agreement with Abiomed, Inc. As outlined by the agreement, Abiomed will invest $15 million in Shockwave and […]
Contego Medical Receives 510(k) Clearance for the Vanguard IEP Peripheral Angioplasty System with Integrated Embolic Protection
RALEIGH, N.C., Dec. 7, 2018 /PRNewswire/ — Contego Medical announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Vanguard IEP® Peripheral Balloon Angioplasty System with Integrated Embolic Protection. Contego Medical is a medical device company developing and commercializing a suite of next-generation devices that address […]
Inari Medical Announces First Patient Enrolled in FLASH Registry Using the FlowTriever System for Pulmonary Embolism
IRVINE, Calif., Dec. 6, 2018 /PRNewswire/ — Inari Medical, Inc. announced today the enrollment of the first patient in the FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (“FLASH”) using the FlowTriever® System for the treatment of pulmonary embolism (PE). FLASH is a 500-patient prospective, multicenter registry study to evaluate real world outcomes […]
Avinger Announces Commercial Launch in Australia
REDWOOD CITY, Calif., Dec. 06, 2018 (GLOBE NEWSWIRE) — Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company that designs and develops the first-ever image-guided, catheter-based system that diagnoses and treats patients with peripheral artery disease (PAD), today announced the commercial launch of its Pantheris image-guided atherectomy system in Australia. Avinger […]
Caelum Biosciences Announces Two Oral Presentations of Additional Data from Phase 1b Study of Anti-Amyloid mAb CAEL-101 and Preclinical Imaging Study at 60th American Society of Hematology Annual Meeting
NEW YORK, Dec. 04, 2018 (GLOBE NEWSWIRE) — Caelum Biosciences, Inc. (“Caelum”), a company focused on developing treatments for rare and life-threatening diseases, today announced additional global longitudinal strain (“GLS”) data from the Phase 1b study of CAEL-101, a light chain fibril-reactive monoclonal antibody (“mAb”) 11-1F4, in patients with cardiac amyloid light […]
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