Tag: cardiac surgery

Ortho Clinical Diagnostics Supports ERAS® Cardiac Surgery Consensus Statement of Best Practices to Enhance Recovery After Heart Surgery

RARITAN, N.J., May 1, 2018 /PRNewswire/ — Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, welcomes and supports today’s inclusion of the biomarkers in the NephroCheck® Test, an FDA-cleared and CE-marked urine test that indicates kidney stress in advance of acute kidney injury (AKI), in consensus guidelines released by ERAS® Cardiac Surgery. The new guidelines were presented as part […]

LivaNova Bicarbon Aortic Valves Receive CE Mark for Expanded Use Labeling with Lower-Dose Blood Thinners in Low-Risk Patients

LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, has received CE Mark approval for its Bicarbon® aortic valves for use with low-dose anticoagulant therapy. The expanded CE labeling means that a lower international normalized ratio (INR), the standardized index used to measure blood coagulability, can be targeted following Bicarbon aortic valve […]

LivaNova Announces Enrollment for PERFECT Perceval Valve Clinical Trial in China

LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, has announced the first patient enrollment in the Perceval® Valve Clinical study for Chinese Registration (“PERFECT”) Trial. The study is a pre-market, prospective, single-arm trial. The PERFECT trial is being conducted to demonstrate the safety and effectiveness of the Perceval sutureless aortic heart […]

LivaNova Announces CE Mark for PureFlex Arterial Cannulae Line for Conventional Cardiac Surgery

Company celebrates new design that delivers improved flexibility, clarity and control LONDON–(BUSINESS WIRE)– LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, today announced it has achieved CE Mark for its new PureFlexTM line of adult arterial cannulae. Engineered to improve the critical link between the patient and extracorporeal circulation, PureFlex cannulae provide curved and […]

CytoSorbents Gets FDA Greenlight For Pivotal Study of CytoSorb in Cardiac Surgery

MONMOUTH JUNCTION, N.J., Dec. 21, 2017 /PRNewswire/ — CytoSorbents (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its flagship CytoSorb® blood filter to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that the U.S. Food and Drug Administration (FDA) has granted approval of its REFRESH 2 Investigational Device Exemption (IDE) application, with conditions. These […]

CryoLife Announces Enrollment of First Patients in BioGlue Clinical Trial in China

ATLANTA, Nov. 6, 2017 /PRNewswire/ — CryoLife, Inc. (NYSE: CRY),a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that enrollment has started in the Company’s BioGlue clinical trial in China. The results from the trial will serve as the basis of the Company’s regulatory submission to the Chinese Food and […]

CytoSorb® Usage During Valve Replacement Surgery for Infective Endocarditis Helps Stabilize Patients and May Improve Survival

MONMOUTH JUNCTION, N.J., Oct. 19, 2017 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using CytoSorb® blood purification to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, highlights the largest endocarditis valve replacement study using CytoSorb published to date entitled, “Hemoadsorption treatment of patients with acute infective endocarditis during surgery with cardiopulmonary bypass – […]

Jeffrey H. Burbank Joins CryoLife Board of Directors

ATLANTA, Oct. 2, 2017 /PRNewswire/ — CryoLife, Inc. (NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced the appointment of Jeffrey H. Burbank to its Board of Directors effective September 29, 2017. Pat Mackin, Chairman, President, and Chief Executive Officer, commented, “Jeff has over 30 years of in-depth management experience in medical devices, highlighted […]

Newly Published Peer Reviewed Study Reveals Benefits Of ClearFlow’s PleuraFlow ACT System

ANAHEIM, Calif.–(BUSINESS WIRE)–ClearFlow Inc., a medical device company based in Anaheim, California, has announced the publication of significantly positive results in a study evaluating the company’s PleuraFlow® Active Clearance Technology® System. Data from a peer-reviewed clinical study indicating a marked reduction in Postoperative Atrial Fibrillation (POAF) among patients with active clearance of chest tubes after heart surgery was […]

LivaNova Announces Publication of Literature Review Highlighting the Clinical Value and Safety of the Perceval Sutureless Valve for Aortic Valve Replacement

LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, today announced the publication of the analysis, “The Perceval® Sutureless Aortic Valve: Review of Outcomes, Complications and Future Direction,” by Powell, Pelletier, Chu, Bouchard, Melvin and Adams in the latest issue of Innovations1. The literature review, which included a meta-analysis of 89 studies, […]