Coronary/Structural Heart

NEXEL Earns the First ISO/IEC 17025:2017 Accreditation for iPSC-derived Cardiomyocyte-based Cardiac Safety Testing

SEOUL, South Korea–(BUSINESS WIRE)–NEXEL, a global leader in induced pluripotent stem cell (iPSC) technology, announced today that it has achieved ISO/IEC 17025:2017 quality standard for laboratory testing, the world’s most respected quality management standard, by the Korea Laboratory Accreditation Scheme(KOLAS). KOLAS is a signatory of the International Laboratory Accreditation Cooperation […]

Northwell cardiac surgery, cardiology programs rank among New York’s best

Five Northwell hospitals on Long Island and NYC distinguished for superior cardiac outcomes NEW HYDE PARK, NY – Two newly released New York State Department of Health (DOH) reports rank five Northwell Health hospitals as among the state’s best for cardiac surgery and percutaneous coronary interventions (PCI), a non-surgical procedure […]

First Patient Enrolled in U.S. STAR-D Pivotal Trial Evaluating the DrugSorb™-ATR Antithrombotic Removal System to Remove Apixaban and Rivaroxaban During Cardiothoracic Surgery

MONMOUTH JUNCTION, N.J., April 29, 2022 /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-Direct Oral Anticoagulants (STAR-D) double-blind, randomized, controlled clinical trial designed to […]

U.S. Food and Drug Administration Approves Camzyos™ (mavacamten) for the Treatment of Adults With Symptomatic New York Heart Association Class II-III Obstructive Hypertrophic Cardiomyopathy (HCM) to Improve Functional Capacity and Symptoms

Camzyos is the first and only FDA-approved cardiac myosin inhibitor that specifically targets the source of obstructive HCM Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) […]

TransMedics Receives FDA PMA Approval of OCS™ DCD Heart Indication

ANDOVER, Mass., April 28, 2022 /PRNewswire/ — TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its OCS™ Heart System for […]

Abbott Strengthens Left Atrial Appendage Closure Leadership With U.S. Availability of Amplatzer™ Steerable Delivery Sheath for the Company’s Amulet™ Device

First and only steerable delivery system designed to help seal the left atrial appendage (LAA) in people with atrial fibrillation who are at an increased risk of stroke Now available in the U.S., Abbott’s steerable sheath offers precise and flexible placement when used with the company’s Amplatzer Amulet LAA Occluder […]

inHEART INITIATES RANDOMIZED CONTROLLED TRIAL FOR ITS AI-ENABLED DIGITAL TWIN OF THE HEART

A first-of-its-kind study comparing image-guided ventricular tachycardia (VT) ablation to conventional, catheter-based strategies to evaluate efficiency and efficacy of image-guided procedures in cardiac arrythmia patients. CAMBRIDGE, Mass. and PESSAC, France, April 28, 2022 /PRNewswire/ — inHEART Inc., a privately-held medical device company delivering the world’s most sophisticated, AI-enabled, digitally-rendered 3D models of the heart, announced […]

Neovasc Comments on European Heart Journal Publication

Report demonstrates objective improvements in patients suffering from microvascular dysfunction VANCOUVER and MINNEAPOLIS, April 28, 2022 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) today announced that the European Heart Journal has published an article entitled, “Impact of the Coronary Sinus Reducer on Absolute Blood Flow and Microvascular Resistance Case Report.” […]

CareDx Extends Artificial Intelligence Leadership to Heart Transplantation

New Addition to CareDx HeartCare Multimodality Portfolio Can Enable More Precise, Personalized Patient Care SOUTH SAN FRANCISCO, Calif., April 28, 2022 (GLOBE NEWSWIRE) — CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, […]

Paragonix Technologies SherpaPak® Improves 1-Year Survival in Heart Transplant Patients in Real-World Study

GUARDIAN Registry data presented at ISHLT 2022 has shown a 72% reduction (p=0.005) in Severe PGD (primary graft dysfunction) and a 39% reduction (p=0.03) in Mechanical Circulatory Support, in addition to improvement in 1-year survival1,2 CAMBRIDGE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc., a leading organ preservation provider, announces today groundbreaking research from […]