Regulatory

Neovasc Announces Receipt of German NUB Status 1 Designation for Neovasc Reducer™ Procedure for Treatment of Refractory Angina

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 […]

FDA Grants RMAT Designation For Mesoblast’s Cell Therapy in Heart Failure Patients With LVADs

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 […]

XableCath Scores FDA Clearance for Broadly Effective Catheter

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 […]

FDA Approves Amgen’s Repatha® (evolocumab) To Prevent Heart Attack And Stroke

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 […]

Essential Medical Release: The MANTA Large Bore Vascular Closure Device To Be Evaluated In A 500-Patient European Post Market Clinical Registry

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 […]

FDA Warns Physicians on Endoleaks With Stent Grafts

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 […]

Medtronic HeartWare(TM) HVAD(TM) System Approved for Destination Therapy

DUBLIN – September 27, 2017 – Medtronic plc (NYSE: MDT) has received U.S. Food and Drug Administration (FDA) approval for its HeartWare(TM) HVAD(TM) System as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants. The HVAD System, a left ventricular assist device or LVAD, […]

LivaNova (LIVN) And MicroPort Scientific (MCRPF) Announce The Approval Of Rega Pacemakers By The China Food And Drug Administration

LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN) (“LivaNova”) and MicroPort Scientific Corporation (HK:00853) (“MicroPort”), today announced that the companies’ Shanghai-based joint venture MicroPort Sorin Cardiac Rhythm Management Co. Ltd. (“MSC” or the “joint venture”) obtained approval for its family of RegaTM pacemakers from the China Food and Drug Administration. Not only are Rega pacemakers […]