Coronary/Structural Heart

SANUWAVE® Rebrands to Reflect Evolved Wound Care Solutions

“Energy First” Protocol Improves Clinical Outcomes SUWANEE, Ga.–(BUSINESS WIRE)–SANUWAVE Health, Inc. (OTCQB: SNWV), focused on the development and commercialization of a robust and innovative advanced wound care product portfolio for the repair and regeneration of skin and vascular structures, today announced its rebranding. The new brand reflects the evolution of […]

LivaNova Receives FDA 510(k) Clearance for B-Capta, the New In-Line, Blood-Gas Monitoring System Integrated Into the S5 Heart-Lung Machine

Intuitive, optical-based technology system now available around the world LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for B-Capta®, the new in-line, blood-gas monitoring system integrated into the market-leading S5® heart-lung machine (HLM). The system is […]

U.S. FDA Approves CytoSorbents to Initiate U.S. STAR-T Trial For Ticagrelor Removal During Cardiothoracic Surgery

MONMOUTH JUNCTION, N.J., April 19, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care leader whose flagship E.U. approved CytoSorb® blood purification technology is intended to treat deadly conditions in critically-ill and cardiac surgery patients, announces that the U.S. Food and Drug Administration (FDA) has granted conditional approval of its investigational device exemption (IDE) application for […]

Windtree Therapeutics Announces New Istaroxime Expedited Review Filing of Patent

Company Continues to Leverage Data to Strengthen the Istaroxime Patent Estate WARRINGTON, Pa., April 19, 2021 /PRNewswire/ — Windtree Therapeutics, Inc. (NasdaqCM: WINT) (“Windtree” or the “Company”), a biotechnology and medical device company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today announced it has filed a Track One […]

Vaica to Offer Anticoagulation Medication Adherence & Monitoring solution

TEL AVIV, Israel, April 19, 2021 /PRNewswire/ — Vaica™ Medical, an innovation leading provider in medication adherence and remote patient management (RPM) is announcing its anti-coagulation (blood clotting) remote management solution. The need to maintain an optimal blood viscosity levels is pertinent for at-risk patients with Thrombotic Predisposition (hypercoagulable states), heart rhythm disorders, […]

Neovasc Comments on EuroIntervention Article

VANCOUVER and MINNEAPOLIS, April 19, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) today announced that the journal EuroIntervention has published an article entitled, “Coronary Sinus Reducer Implantation Results in Improved Oxygen Kinetics at Cardiopulmonary Exercise Test in Patients with Refractory Angina.” The article, authored by Carlo Zivelonghi, M.D., Antwerp […]

LivaNova Achieves Clinical Milestone in Heart Failure Program

300th patient randomized in ANTHEM-HFrEF pivotal study LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced it has randomized the 300th patient in the Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure With Reduced Ejection Fraction (ANTHEM-HFrEF) Pivotal Study, which was approved by the U.S. Food and Drug Administration (FDA) […]

Elucid Presents Results of the EVAPORATE Study at ESC Preventive Cardiology 2021 Late Breakers

Elucid Software Quantifies Plaque Morphology to Enable Better Assessment of IPE Treatment Effects BOSTON–(BUSINESS WIRE)–Elucid, a medical technology company developing AI software for physicians to optimize the treatment of patients with known or suspected vascular disease, announced that first author and Elucid founder Andrew Buckler presented findings today from the […]

Neovasc Provides Tiara TA Update

VANCOUVER and MINNEAPOLIS, April 16, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), today announced that the Tiara Transapical system (“Tiara TA”) will be unable to receive a European CE mark under the current Medical Device Directive regulations (“MDD”) ending on May 26, 2021. The Company is […]

Seigla® Medical Receives CE Mark for LiquID™ Guide Catheter Extension

MINNEAPOLIS, April 16, 2021 /PRNewswire/ — Seigla Medical, Inc., announced conformité européenne (CE) Mark for the company’s LiquID™ Guide Catheter Extension for use in coronary and peripheral vasculature interventions. Guide catheter extensions are a crucial tool used by cardiologists worldwide to assist in the delivery of stents and other interventional devices. In addition, […]