Coronary/Structural Heart

FDA Issues Emergency Use Authorization for Impella RP as Therapy for COVID-19 Patients with Right Heart Failure

DANVERS, Mass.–(BUSINESS WIRE)–The United States Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Impella RP to include patients suffering from COVID-19 related right heart failure or decompensation, including pulmonary embolism (PE). Abiomed (NASDAQ: ABMD) manufactures Impella RP. Impella RP is a temporary heart pump that provides circulatory support for […]

Amarin Plans to Increase VASCEPA® (icosapent ethyl) Promotion and Education

Significant Opportunity Seen as Patient Visits Resume to Emphasize VASCEPA as the First and Only Drug Approved for Its Current Cardiovascular Risk Reduction Indication DUBLIN, Ireland and BRIDGEWATER, N.J., June 01, 2020 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN), today announced that it intends to increase the level and breadth of […]

Resverlogix Plans COVID-19 Clinical Trial Program Launch

Epigenetic BET-inhibition to combat COVID-19 CALGARY, Alberta, June 01, 2020 (GLOBE NEWSWIRE) — Resverlogix Corp. (“Resverlogix” or the “Company”) (TSX:RVX) is pleased to announce that it is moving forward with a plan to further evaluate apabetalone’s impact on COVID-19 in both a preclinical and clinical setting. A first step will be to […]

BRILINTA Approved in the US to Reduce the Risk of a First Heart Attack or Stroke in High-Risk Patients with Coronary Artery Disease

New BRILINTA indication expands treatment to high-risk coronary patients without a history of stroke or heart attack WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca’s BRILINTA® (ticagrelor) has been approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD), the most common type of […]

Foldax Wins 2020 MedTech Breakthrough Award for Cardiovascular Technology Innovation

Annual Awards Program Recognizes Outstanding Health & Medical Technology Products and Companies SALT LAKE CITY–(BUSINESS WIRE)–Foldax® announced today that MedTech Breakthrough, an independent market intelligence organization that recognizes the top companies, technologies and products in the global health and medical technology market, has selected its Tria™ LifePolymer™ heart valve technology […]

Per FDA Guidance, Medtronic Temporarily Modifies Several Cardiopulmonary Product Indications for Longer Duration Use in ECMO Therapy to Address COVID-19

DUBLIN, May 29, 2020 (GLOBE NEWSWIRE) — During this critical time, Medtronic remains committed to our strategy of delivering critical care products ― designed and indicated for Extracorporeal Membrane Oxygenation (ECMO) ― to treat patients around the world. Following guidance issued by the U.S. Food and Drug Administration (FDA) on April 6, […]

Gentherm Medical’s Hemotherm® Model 400CE Cardiovascular Heater/Cooler Device Now Able to be Utilized for Treatment of COVID-19 Patients Under U.S. Food and Drug Administration Emergency Use Authorization for ECMO Devices

NORTHVILLE, Mich., May 28, 2020 (GLOBE NEWSWIRE) — Gentherm (NASDAQ: THRM), a global market leader and developer of innovative thermal management technologies today announced that via the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), the Company’s Hemotherm® Model 400CE Dual Reservoir Cooler-Heater can be used to treat patients […]

New Data on LivaNova Perceval Sutureless Aortic Valve Show Consistent Outcomes, Lower Procedure Times Compared to Sutured Valves

PERSIST-AVR study results presented at American Association for Thoracic Surgery Annual Meeting LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, presented the first data from the Perceval® Sutureless Implant Versus Standard-Aortic Valve Replacement (PERSIST-AVR) clinical study at the 100th Annual Meeting of the American Association of Thoracic Surgery (AATS). The study demonstrated that the […]

Vanderbilt Researcher Receives Award to Study LVADs in Heart Failure Patients

Medtronic sponsors research aimed at improving patient outcomes ADDISON, Texas, May 28, 2020 (GLOBE NEWSWIRE) — Jordan R.H. Hoffman, MD, Assistant Professor in Cardiac Surgery at Vanderbilt University School of Medicine in Nashville, TN., has received the O.H. Frazier Award in MCS Translational Research sponsored by Medtronic and administered by […]

PhaseBio Launches Clinical Trial to Evaluate PB1046 as a Treatment for Hospitalized COVID-19 Patients

PhaseBio receives clearance of IND application from U.S. FDA under Coronavirus Treatment Acceleration Program (CTAP) “VANGARD” trial will assess the efficacy and safety of PB1046 in hospitalized COVID-19 patients at high risk for rapid clinical deterioration and acute respiratory distress syndrome Based on FDA feedback, PhaseBio believes that positive, clearly […]