Coronary/Structural Heart

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 […]

CARMAT Confirms the Definitive Approval of its “Forfait Innovation” Dossier by the French National Authority for Health (HAS)

With this favorable opinion, CARMAT will request financing of its device within the framework of a clinical study in France PARIS–(BUSINESS WIRE)–Regulatory News: 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 […]

Windtree Presents New Istaroxime Phase 2b Study Analysis at the American College of Cardiology (ACC) Congress

Efficacy of 24 Hour Istaroxime Infusion is Similar Between Caucasian and Asian Patients Hospitalized for Acute Heart Failure WARRINGTON, Pa., April 6, 2020 /PRNewswire/ — Windtree Therapeutics, Inc. (OTCQB: WINT), a biotechnology and medical device company focused on developing drug product candidates and medical device technologies to address acute cardiovascular and pulmonary diseases, […]

SHOCKWAVE COMPLETES ENROLLMENT IN PIVOTAL STUDY FOR CORONARY INTRAVASCULAR LITHOTRIPSY

Last Patient Enrolled in DISRUPT CAD III, the U.S. FDA IDE Study for IVL in Severely Calcified Coronary Arteries SANTA CLARA, Calif., April 06, 2020 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, […]

Mardil Medical Completes Treatment Of Third Patient In VenTouch™ Device Trial

MINNEAPOLIS, April 3, 2020 /PRNewswire/ — Mardil Medical, Inc., today announced the successful completion of treatment for the third patient in the clinical trial of its improved VenTouch™ device.  VenTouch is a combination therapy which simultaneously treats the distorted valve, the dilated ventricle and the displaced papillary muscles in patients suffering from Type IIIb Functional Mitral Valve […]

CHF Solutions Doubles Production Staff of Aquadex SmartFlow™ Consoles Due to Hospital Demand

EDEN PRAIRIE, Minn., April 02, 2020 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS), a medical device company dedicated to changing the lives of patients suffering from fluid overload, announced that it has doubled the production staff that builds its next generation Aquadex SmartFlow consoles in response to increased demand from […]

BIOCARDIA ANNOUNCES POSITIVE DSMB RECOMMENDATION TO CONTINUE PHASE III PIVOTAL CARDIAMP HEART FAILURE STUDY, AS PLANNED

Company to Host Conference Call with National Co-Principal Investigators Today at 4:15 p.m. ET to Provide Study Updates SAN CARLOS, Calif., March 31, 2020 (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) […]