IRVINE, Calif., Nov. 16, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it has received CE Mark for the SAPIEN 3 Ultra system for transcatheter aortic valve replacement […]
Regulatory
Terumo Cardiovascular Group Announces 510(k) Clearance for the CDI® Blood Parameter Monitoring System 550, Adding New Parameter for Oxygen Delivery
ANN ARBOR, Mich., Nov. 14, 2018 /PRNewswire/ — Terumo Cardiovascular Group, a global leader in cardiovascular surgery technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CDI® Blood Parameter Monitoring System 550, adding real-time monitoring of […]
Medtronic Receives CE Mark Approval for the Valiant Navion(TM) Thoracic Stent Graft System
DUBLIN – November 13, 2018 – Medtronic plc (NYSE:MDT) today announced it has received CE Mark approval for the Valiant Navion(TM) thoracic stent graft system for the minimally invasive repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms […]
MEDTRONIC BEGINS RENAL DENERVATION STUDY FOR HIGH BLOOD PRESSURE PATIENTS PRESCRIBED ANTI-HYPERTENSIVE MEDICATION
DUBLIN – November 8, 2018 – Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval to begin a clinical trial to evaluate the Symplicity Spyral(TM) renal denervation system in patients with high blood pressure (hypertension) who are already […]
Micro Medical Solutions’ New MicroStent with 120 cm Delivery Catheter Receives CE Mark Approval
WILMINGTON, Mass., Nov. 5, 2018 /PRNewswire/ — Micro Medical Solutions (MMS), an innovator in the field of microvascular interventions designed to improve clinical outcomes and quality of life, announced today that it has received CE Mark approval for a 4Fr.-compatible MicroStent 120 […]
Medtronic Receives FDA Approval for Valiant Navion(TM) Thoracic Stent Graft System
DUBLIN – October 23, 2018 – Medtronic plc (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval for the Valiant Navion(TM) thoracic stent graft system for the minimally invasive repair of all lesions of the descending […]
Boston Scientific Prevails in German Edwards Lifesciences Litigation
MARLBOROUGH, Mass., Oct. 23, 2018 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced the District Court of Dusseldorf, Germany has determined that Edwards Lifesciences Corporation’s Sapien 3 Ultra™ device infringed a patent – established by Symetis SA, a subsidiary of […]
Correvio Announces Intention to Re-File Brinavess® NDA in Second Quarter 2019
VANCOUVER, Oct. 23, 2018 /PRNewswire/ – Correvio Pharma Corp. (NASDAQ: CORV /TSX: CORV), a specialty pharmaceutical company focused on providing high-quality brands to acute care physicians and patients, today announced that, based on productive pre-NDA discussions with the U.S. Food […]
ABBOTT’S HEARTMATE 3 HEART PUMP NOW FDA APPROVED FOR ADVANCED HEART FAILURE PATIENTS NOT ELIGIBLE FOR A HEART TRANSPLANT
ABBOTT PARK, Ill., Oct. 19, 2018 /PRNewswire/ — Abbott (NYSE: ABT) announced today that the HeartMate 3™ Left Ventricular Assist Device (LVAD) has received U.S. Food and Drug Administration (FDA) approval as a destination therapy for people living with advanced heart failure. With the approval, physicians […]
MC3 Cardiopulmonary Announces FDA Clearance of Crescent™ for Veno-Venous Extracorporeal Membrane Oxygenation (ECMO)
DEXTER, Mich., Oct. 18, 2018 /PRNewswire/ — MC3 (mc3corp.com) today announced the launch of the Crescent™Jugular Dual Lumen Catheter, the first such device cleared by FDA for ECMO (Extracorporeal membrane oxygenation) in the United States. MC3’s Crescent catheter is placed through the jugular […]