Coronary/Structural Heart

Alnylam Pharmaceuticals Announces Initiation of APOLLO-B Phase 3 Study of Patisiran for the Treatment of Transthyretin Amyloidosis with Cardiomyopathy

– APOLLO-B Will Enroll Patients with Both Hereditary and Wild-Type Amyloidosis – CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the Company has initiated APOLLO-B, a global Phase 3 placebo-controlled clinical trial of patisiran, an intravenously administered RNAi therapeutic, for the treatment of transthyretin […]

BioCardia Announces Positive DSMB Recommendation to Continue Phase 3 Pivotal CardiAMP Heart Failure Study as Planned

SAN CARLOS, Calif., Sept. 16, 2019 (GLOBE NEWSWIRE) — BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the Phase III pivotal CardiAMP Heart Failure Trial, which included safety […]

FDA Grants Fast Track Designation for FARXIGA in Heart Failure

WILMINGTON, Del.–(BUSINESS WIRE)– AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of FARXIGA (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure in adults with heart failure with reduced ejection fraction (HFrEF) or […]

CARMAT announces FDA conditional approval to initiate US clinical feasibility study of its total artificial heart

CARMAT provided sufficient data to support the initiation of a human clinical study Study to include 5 patients in selected renowned US institutions CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage […]

HeartFlow Announces FDA Clearance for HeartFlow Planner

REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow, Inc. today announced that it has obtained clearance from the U.S. Food and Drug Administration (FDA) for the HeartFlow Planner, a non-invasive, real-time virtual modeling tool for coronary artery disease (CAD) intervention. The HeartFlow Planner will enable interventional cardiologists to virtually model clinical scenarios vessel-by-vessel, explore treatment strategies […]

Correvio Highlights FDA Acceptance of United Therapeutics’ Trevyent New Drug Application

VANCOUVER, Sept. 12, 2019 /PRNewswire/ – Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today highlighted that the U.S. Food and Drug Administration (FDA) has accepted for review United Therapeutics Corporation’s (NASDAQ: UTHR) New Drug Application (NDA) for Trevyent® (treprostinil) for the treatment of pulmonary arterial hypertension […]

REDUCE FMR Study Shows Cardiac Dimensions’ Carillon® System Significantly Improves Mitral Regurgitation And Slows Worsening Of Heart Failure

KIRKLAND, Wash., Sept. 12, 2019 /PRNewswire/ — Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure (HF), today announced the publication of the REDUCE FMR clinical study of its Carillon Mitral Contour System®. The Carillon® System is a right heart […]

V-Wave Receives Second FDA Breakthrough Device Designation: Interatrial Shunt for Pulmonary Arterial Hypertension

CAESAREA, Israel, Sept. 12, 2019 /PRNewswire/ — V-Wave Ltd., a privately held medical device company developing novel implantable interatrial shunt devices, today announced that the U.S. Food and Drug Administration (FDA) has granted the company a second Breakthrough Device Designation – the first was for its interatrial shunt for Heart Failure (HF), and […]

MyoKardia to Evaluate Mavacamten as an Alternative to Septal Reduction Therapy in Obstructive Hypertrophic Cardiomyopathy Patients

Planned Study Will Assess Effect of Mavacamten on the Need for SRT Among HCM Patients Referred for Invasive Procedures SOUTH SAN FRANCISCO, Calif., Sept. 10, 2019 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK), today announced that it will study mavacamten as a therapeutic alternative to septal reduction therapy (SRT). The […]