Coronary/Structural Heart

Foldax®, Inc. Successfully Completes First-In-Human Use of Next-Generation Tria Polymer Heart Valve for the Treatment of Aortic Valve Disease

SALT LAKE CITY–(BUSINESS WIRE)–Foldax, Inc. today announced its first-in-human use of the Tria heart valve under its FDA Early Feasibility Study (EFS) for the treatment of aortic valve disease. Clinicians at Beaumont Hospital, Royal Oak, in Michigan, implanted this innovative flexible polymer heart valve, which has the potential to address […]

Medicure Announces Launch of New and Improved ReDS™ PRO

WINNIPEG, Sept. 17, 2019 /PRNewswire/ – Medicure Inc. (“Medicure” or the “Company”) (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, is pleased to announce the launch of the ReDSTM PRO (“ReDSTM PRO”) system, the next generation of lung fluid management technology for heart failure. The debut of the new system took place at the recent Heart […]

Sensible Medical announces ReDS™ Pro, the next generation of market leading lung fluid management technology for heart failure

Non-invasive monitoring technology assists in managing heart failure patients TENAFLY,  N.J., Sept. 14, 2019 /PRNewswire/ — Sensible Medical Innovations today announced the launch of the ReDSTM PRO system. The debut of the new system was at the Heart Failure society of America conference in Philadelphia, PA. ReDSTM PRO is optimized for the Point-of-Care, designed for use in […]

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 […]