Coronary/Structural Heart

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 […]

Neovasc Has Filed for CE Mark for Tiara TA Transapical Mitral Valve Replacement System

Less invasive approach provides hope for the millions of patients that suffer from leaky mitral valves VANCOUVER and MINNEAPOLIS, MN, May 27, 2020 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive […]

CARMAT Announces the First Implantation of Its Total Artificial Heart in Denmark

This implant, performed at Rigshospitalet in Copenhagen, marks the resumption of the recruitment in the PIVOTAL study and brings the total number of patients to thirteen CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people […]

Amarin Supports Trial to Investigate the Effects of VASCEPA® (icosapent ethyl) in the Treatment of COVID-19

DUBLIN, Ireland and BRIDGEWATER, N.J., May 21, 2020 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN), today announced support for a clinical trial to investigate the effects of icosapent ethyl (IPE) (VASCEPA®) on inflammatory biomarkers and other patient outcomes in individuals with COVID-19. The trial is sponsored by the Canadian Medical and […]

Mentice Expands its Coronary Product Portfolio With an Advanced Software Solution for Coronary Interventions

Coronary Advanced to Help Fellows and Attending Interventional Cardiologists to Perfect Skills in Complex Scenarios STOCKHOLM, May 21, 2020 /PRNewswire/ — Mentice AB (STO: MNTC), a world leader in high-fidelity endovascular simulation introduces Coronary Advanced for select VIST® platforms. Following the introduction of Coronary Essentials and Coronary Intermediate, Coronary Advanced is the most […]

PROTECT III Study Shows Placing Impella Prior to High-Risk PCI is Associated with Lower Mortality Compared to Bailout PCI

Women Disproportionately Impacted with Bailout DANVERS, Mass.–(BUSINESS WIRE)–Data from more than 1,000 patients presented during the virtual 2020 Society for Cardiovascular Angiography & Interventions (SCAI) Scientific Sessions demonstrates Impella reduced in-hospital mortality when placed before a non-emergent percutaneous coronary intervention (PCI) is performed. As detailed in the online presentation, the research found, in […]