The Latest Cardiac and Vascular News
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 in severe, symptomatic aortic stenosis patients. “The SAPIEN 3 Ultra […]
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 oxygen delivery as one of 12 critical blood parameters. Oxygen […]
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 (TAA), blunt traumatic aortic injuries (BTAI), penetrating atherosclerotic ulcers (PAU), […]
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 prescribed anti-hypertension medications. The SPYRAL HTN-ON MED Trial is the […]
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 cm delivery catheter, as well as MicroStent devices in five […]
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 thoracic aorta, including thoracic aortic aneurysms (TAA), blunt thoracic aortic […]
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 Boston Scientific – specific to the fabric used on the […]
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 and Drug Administration (FDA), Correvio plans to resubmit the Brinavess® […]
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 can now offer the HeartMate 3 system to patients not […]
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 vein and is connected to an ECMO system, which removes […]
