SAN CARLOS, Calif., Oct. 21, 2021 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA] a company focused on developing cellular and cell derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the treatment of the first patient in its Phase III pivotal CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial for patients […]
Coronary/Structural Heart
Longeveron Announces Activation of Two New Clinical Sites in ELPIS II Trial of Lomecel-B for Hypoplastic Left Heart Syndrome (HLHS)
MIAMI, Oct. 20, 2021 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for chronic, aging-related and life-threatening conditions, announced today the activation of two new clinical sites for the currently enrolling ELPIS II Trial, evaluating Lomecel-B injection into the myocardium of […]
CytoSorbents Comments on REMOVE Study Presentation
MONMOUTH JUNCTION, N.J., Oct. 20, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using CytoSorb®1 blood purification, makes additional comments on the investigator-initiated REMOVE study following the formal presentation of trial results on Saturday, October 16th at the European Association for Cardio-Thoracic Surgery (EACTS) annual meeting in Barcelona, Spain. […]
JenaValve Announces First European Commercial Implants with the Trilogy™ Heart Valve System
IRVINE, Calif., Oct. 18, 2021 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced the first commercial implants with the Trilogy Heart Valve System in Europe. The procedures, which included treatment of both aortic regurgitation1 (AR) and aortic stenosis1 (AS), took place […]
Cook Medical Issues Voluntary Recall of Transseptal Needle and Transseptal Needle With Catheter
BLOOMINGTON, Ind.–(BUSINESS WIRE)–Cook Medical issued a global, voluntary recall of the Transseptal Needle and the Transseptal Needle with Catheter. This recall includes all unexpired lots for both of these products. The needles were recalled due to complaints of rust on the products. Use of affected products could result in increased […]
FEops HEARTguide Authorized by FDA for Unprecedented LAAo Planning Capabilities
GENT, Belgium–(BUSINESS WIRE)–FEops today announced that it received De Novo authorization from the U.S. Food and Drug Administration (FDA) for FEops HEARTguide™ pre-operative planning of left atrial appendage occlusion with the Boston Scientific WATCHMAN™ device*. FEops HEARTguide™ will enable physicians to virtually model clinical scenarios with different implant positions and sizes […]
First Patient Enrolled in U.S. STAR-T Pivotal Trial Evaluating the DrugSorb-ATR™ Antithrombotic Removal System to Remove Ticagrelor During Cardiothoracic Surgery
MONMOUTH JUNCTION, N.J., Oct. 14, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced today that the first patient has been enrolled in the Safe and Timely Antithrombotic Removal-Ticagrelor (STAR–T) double-blind, randomized, controlled clinical trial designed to support […]
HeartFlow Announces Enrollment of First Two Patients in REVEALPLAQUE Trial
Trial to evaluate new technology that may help physicians prevent heart attacks in patients REDWOOD CITY, Calif., Oct. 14, 2021 (GLOBE NEWSWIRE) — HeartFlow, Inc., the leader in revolutionizing precision heart care, today announced the commencement of the REVEALPLAQUE (A pRospEctiVe, multicEnter study to AnaLyze PLAQUE using CCTA) trial to evaluate HeartFlow’s non-invasive plaque […]
PLx Pharma, Inc. Issues Statement on Recent USPTF Recommendations on Aspirin Therapy for Primary Prevention of Cardiovascular Disease; PLx’s VAZALORE Specifically Indicated for Secondary Prevention
Aspirin remains an established practice for the prevention of another heart attack or clot-related stroke SPARTA, N.J., Oct. 14, 2021 (GLOBE NEWSWIRE) — PLx Pharma Inc. (NASDAQ: PLXP) (“PLx” or the “Company”), a specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard™ drug delivery platform to provide more effective […]
OpSens Successfully Treats First Patients in Human Clinical Study for TAVR Procedure
Quebec, Quebec, October 13, 2021 – OpSens Inc. (“OpSens” or the “Company”) (TSX:OPS) (OTCQX:OPSSF), a cardiology medical device company providing innovative product solutions based on its patented optical technology, is pleased to announce the commencement of the human clinical study utilizing the SavvyWire, and successful treatment of the first patients. […]
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