The Latest Cardiac and Vascular News
ZWICKAU, Germany, April 12, 2018 /PRNewswire/ — HeartStitch® Trans-Apical Access and Closure device provides safe and effective percutaneous trans-apical access for structural heart procedures and reliable closure. The proven suture-based technique emulates surgical closure without the need for open heart surgery or limited thoracotomy access (open surgical access to the heart between the ribs) when […]
ABBOTT PARK, Ill., March 19, 2018 /PRNewswire/ — Abbott (NYSE: ABT) today announced that the Ministry of Health Labour and Welfare (MHLW) in Japan granted national reimbursement for the company’s MitraClip therapy to treat people with mitral regurgitation, a serious, progressive heart disease in which the mitral valve does not close properly, […]
Participating Hospitals in Germany Now Eligible to Negotiate Reimbursement for Reducer Procedure NASDAQ, TSX: NVCN VANCOUVER, Feb. 1, 2018 /PRNewswire/ – Neovasc, Inc. (NVCN) (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve technologies, today announced that the “Institut für das Entgeltsystem im […]
Patient death prompts safety warning by FDA. Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication – Potential Lack of Treatment (Shock) Delivery Due to Device Failure by FDA.gov ISSUE: FDA is providing information and recommendations regarding the Zoll LifeVest 4000 due to concerns that the device may fail to […]
NEW YORK and MELBOURNE, Australia, Dec. 21, 2017 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO) (ASX:MSB) today announced that the United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for its novel mesenchymal precursor cell (MPC) therapy in the treatment of heart failure patients with left ventricular […]
SALT LAKE CITY–(BUSINESS WIRE)– XableCath, a clinical stage medical device company, announced its XableCath blunt tip support catheter has received clearance from the FDA. The blunt tip catheter facilitates true lumen passage of lesions, both above and below the knee, in the peripheral vasculature. Procedures using the XableCath blunt tip catheters can […]
THOUSAND OAKS, Calif., Dec. 1, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that following priority review of its supplemental Biologics License Application, the U.S. Food and Drug Administration (FDA) approved Repatha® (evolocumab) as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease.1 “We are pleased […]
Gottlieb updates on Puerto Rico med device manufacturing recovery OCTOBER 20, 2017 BY SARAH FAULKNER In the weeks following Hurricanes Irma and Maria, the people and leadership in Puerto Rico have been working to rebuild the island’s infrastructure. The FDA, which has been working with federal and local agencies, today provided an […]
EXTON, Pennsylvania, Oct. 9, 2017 /PRNewswire/ –Essential Medical, Inc. today announced initiation of enrollment in a post market clinical registry in the regions where MANTA is commercially available. Principle Investigator Nicolas Van Mieghem, MD, PhD, Medical Director of the Department of Interventional Cardiology at Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands stated, “MANTA has quickly become […]
Endovascular Graft Systems: Letter to Health Care Providers – Type III Endoleaks Associated with Use [Posted 09/28/2017] AUDIENCE: Risk Manager, Surgery, Cardiology, Radiology ISSUE: The FDA is evaluating recent information regarding Type IIIa and IIIb endoleaks with the use of endovascular graft systems indicated for a procedure known as endovascular […]
