Coronary/Structural Heart

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 […]

Conavi Medical’s Novasight Hybrid System Now In Use at Sunnybrook Health Sciences Centre

Sunnybrook’s Schulich Heart Program to provide the latest innovative hybrid imaging of coronary arteries for complex cases TORONTO–(BUSINESS WIRE)–Conavi Medical Inc. (www.conavi.com), a leader of hybrid imaging guidance for common minimally invasive heart procedures, and Sunnybrook Health Sciences Centre, today announced that the Novasight Hybrid System is now being used […]

AMGEN ANNOUNCES RESULTS FROM TWO OPEN LABEL EXTENSION STUDIES OF REPATHA® (EVOLOCUMAB)

Studies Showed Sustained Reduction in LDL-C With no new Safety Findings The Combined Studies Evaluated Safety and Tolerability of Repatha in More Than 6,600 Patients for Over Five Years After Completing the Phase 3 FOURIER Trial Repatha is the Longest Studied PCSK9i THOUSAND OAKS, Calif., April 27, 2022 /PRNewswire/ — Amgen (NASDAQ:AMGN) […]

ISHLT Launches Foundation to Fund Research in Thoracic Transplantation, Mechanical Circulatory Support, and Pulmonary Hypertension

BOSTON, April 27, 2022 /PRNewswire/ — The International Society for Heart and Lung Transplantation (ISHLT) has established a new sister organization: the ISHLT Foundation. This new entity serves as the charitable arm of ISHLT, and will fund a global portfolio of research grants and fellowship awards to improve patient care for advanced heart […]