The Latest Cardiac and Vascular News
IRVINE, Calif., June 28, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today commented on the announcement by the U.S. Centers for Medicare and Medicaid Services (CMS) about a National Coverage Analysis (NCA) for transcatheter aortic valve replacement (TAVR): CMS […]
IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative treatments for aortic disorders, announced 1-year results from the LUCY (Evaluation of FemaLes who are Underrepresented Candidates for Abdominal Aortic AneurYsm Repair) registry as reported on Saturday, June 23rd at the 2018 Society for Vascular Surgery Annual Meeting. The LUCY study […]
SUNNYVALE, Calif.–(BUSINESS WIRE)–Embolx, Inc., a medical device company developing microcatheters for arterial embolization procedures, today announced that the company has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its next generation family of Sniper® Balloon Occlusion Microcatheters, an innovative system for pressure-directed arterial embolization therapy. […]
VANCOUVER, British Columbia, June 27, 2018 (GLOBE NEWSWIRE) — Lexington Biosciences, Inc. (CSE:LNB) (OTCQB:LXGTF) (the “Company” or “Lexington”), a development-stage medical device company, is pleased to announce the completion of the initial HeartSentry study conducted at San Francisco Bay-area Diablo Clinical Research. “We are pleased with the performance of the […]
BREA, Calif., June 27, 2018 /PRNewswire/ — Beckman Coulter Diagnostics announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new high-sensitivity troponin (hsTnI) assay, Access hsTnI, for use on the Access 2, DxI and the entire Access family of immunoassay systems. The Access hsTnI assay […]
REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow, Inc. today announced that UnitedHealthcare now covers the HeartFlow® FFRct Analysis, extending access to their 45 million beneficiaries. With this new coverage, more than 235 million people in the United States now have access to the HeartFlow Analysis — significantly advancing HeartFlow’s mission of transforming cardiovascular care. The […]
SAN JUAN CAPISTRANO, Calif.–(BUSINESS WIRE)–Avenu Medical, Inc. announced today that it has received De Novo marketing authorization from the Food and Drug Administration (FDA) to market its Ellipsys® Vascular Access System, an innovative, minimally-invasive catheter-based system designed for End-Stage Renal Disease (ESRD) patients requiring hemodialysis. The FDA’s action will provide U.S. […]
Advanced Bifurcation Systems (“ABS” or the “Company”), a clinical stage medical device company developing an innovative stenting platform which overcomes the limitations of current approaches for the treatment of bifurcation lesions in coronary angioplasties, today announced that ABS, through its wholly-owned Canadian subsidiary, Advanced Bifurcation Systems Canada, Inc. (“ABS Canada”) has […]
IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that it has appointed Jeffry Fecho as the Company’s Chief Quality Officer, effective as of June 25, 2018 (the “Effective Date”). John Onopchenko, Chief Executive Officer of Endologix, […]
SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc. announced today it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the IMPEDE Embolization Plug. The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. It is available in […]
