Coronary/Structural Heart

Cytokinetics Provides Clinical Trials and Business Update in Response to COVID-19 Pandemic

Top-line Results for GALACTIC-HF Expected in Q4 2020; Enrollment in METEORIC-HF Temporarily Suspended SOUTH SAN FRANCISCO, Calif., April 14, 2020 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today provided an update regarding the company’s clinical trials and business operations related to its response to the COVID-19 pandemic alongside its commitment to […]

Shockwave Completes Enrollment of Coronary Intravascular Lithotripsy Study in Japan

DISRUPT CAD IV Clinical Study to Support Regulatory Device Approval in Japan SANTA CLARA, Calif., April 13, 2020 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, announced today that the company has completed enrollment in […]

U.S. FDA Grants CytoSorb® Emergency Use Authorization for Use in Patients with COVID-19 Infection

MONMOUTH JUNCTION, N.J., April 13, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a  critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced the United States Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) of CytoSorb® for use in patients with COVID-19 […]

ABBOTT’S TRICLIP™ BECOMES FIRST DEVICE OF ITS KIND TO RECEIVE CE MARK FOR MINIMALLY INVASIVE TRICUSPID VALVE REPAIR

– CE Mark for TriClip represents an important treatment option for people with severe tricuspid regurgitation, a difficult-to-manage heart condition – New system offers a proven safe and effective minimally invasive non-surgical solution – The TriClip System leverages Abbott’s proven clip-based technology used in its MitraClip™ transcatheter mitral valve therapy […]

The LSU Health Network Partners With Ninety One Inc. to Bring Artificial Intelligence and Precision Medicine to Cardiology in the Fight Against Covid-19

NEW ORLEANS–(BUSINESS WIRE)–In response to Covid-19, the LSU Health Network will be the first healthcare system in the southeast to bring Ninety One’s advanced algorithms and technologies to assist with analysis of complex medical data for cardiology patients. “The primary aim of the partnership between LSU Health Network and Ninety One […]

Tenax Therapeutics Announces Last Patient Completes Final Visit in its Phase 2 “HELP Study” of Levosimendan for Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction

Top-line Data Readout Remains on Track for Late Q2 2020 MORRISVILLE, N.C.–(BUSINESS WIRE)–Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that the last patient has completed their final visit […]

Acceleron Receives FDA Breakthrough Therapy Designation for Sotatercept in Pulmonary Arterial Hypertension

Sotatercept granted first FDA Breakthrough Therapy designation in pulmonary arterial hypertension since the Agency established the designation in 2012 CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the […]

Liquidia Announces FDA Acceptance of New Drug Application for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension

RESEARCH TRIANGLE PARK, N.C., April 08, 2020 (GLOBE NEWSWIRE) — Liquidia Technologies, Inc. (Nasdaq: LQDA), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel products utilizing its proprietary PRINT® technology, today announced that the U.S. Food and Drug Administration (FDA) accepted for review the Company’s New Drug Application […]

Nitiloop’s NovaCross Earns FDA Clearance for Treating Chronic Total Occlusion (CTO) Prior to PTCA or Stent Intervention

Designed solely for antegrade approach, NovaCross™ is positioned to tap into the $500M CTO market, a market with only few players PARDES HANA, Israel, April 7, 2020 /PRNewswire/ — Nitiloop Ltd. to announce that it has received a 510(k) clearance from the U.S. Food & Drug Administration for its NovaCross™ CTO Microcatheter. The NovaCross™ CTO Microcatheter […]

Quantum Genomics Provides Update on the Impact of the COVID-19 Health Crisis on Clinical Research Activities

PARIS and NEW YORK, April 07, 2020 (GLOBE NEWSWIRE) — Quantum Genomics (Euronext Growth – FR0011648971 – ALQGC), a biopharmaceutical company specializing in developing a new drug class that directly targets the brain to treat difficult-to-treat and resistant hypertension and heart failure, has released an update on how the current COVID-19 […]