MORRISVILLE, N.C., June 02, 2021 (GLOBE NEWSWIRE) — Liquidia Corporation (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for LIQ861 (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH). The FDA confirmed that the resubmission was a complete, […]
Coronary/Structural Heart
Data Published in “JACC Heart Failure”Show Benefit of Carillon Device to Patients Suffering from Functional Mitral Regurgitation & Severe Left Ventricular
On behalf of Cardiac Dimensions, please find key outcomes of the analysis “Percutaneous Mitral-Valve Annuloplasty Versus Optimal Medical Therapy in Patients with Secondary Mitral-Regurgitation and Severe Left-Ventricular Enlargement” published in this month’s JACC: Heart Failure. The manuscript can be viewed here: https://cardiacdimensions.com/wp-content/uploads/docs/Anker-Complete-Publication_May-2021.pdf Key outcomes of the analysis are as follows — in the Carillon […]
Occlutech takes important step towards approval in China
SCHAFFHAUSEN, Switzerland, June 1, 2021 /PRNewswire/ — Occlutech AG (“Occlutech” or the “Company”) today announces that the planned recruitment of 180 patients has been reached in the Company’s trial in China for its ASD Occluder. The Occlutech ASD Occluder is used in the treatment of Atrial Septal Defects (ASD), which is a congenital heart condition. The […]
Sequana Medical Announces First Patient Enrolled in SAHARA DESERT
alfapump® DSR study in Heart Failure patients with persistent congestion GHENT, Belgium, June 01, 2021 (GLOBE NEWSWIRE) — Sequana Medical NV (Euronext Brussels: SEQUA), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces that the first patient has been enrolled in […]
FDA Grants Micro Interventional Devices, Inc. Breakthrough Device Designation for the MIA™-T Percutaneous Tricuspid Annuloplasty System
NEWTOWN, Pa., May 27, 2021 /PRNewswire/ — Micro Interventional Devices (MID) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its MIA™-T Percutaneous Tricuspid Annuloplasty System. The MIA-T system treats moderate-severe tricuspid regurgitation (TR) via a 12F catheter-based system. MID develops proprietary Transcatheter Cardiac Repair (TCR) technologies addressing unmet […]
SINOMED announces the HT Supreme DES has similar performance as the market-leader across the spectrum of lesion complexity
TIANJIN, China, May 27, 2021 /PRNewswire/ — SINOMED, a leading international medical device company, today announced results from the HT Supreme™ Healing-Targeted Drug-Eluting Stent (DES), in complex patients compared to the Xience or Promus family of DES. One-year results were presented at last week’s 2021 EuroPCR annual congress showing that the two […]
FEops HEARTGuide Combines Digital Twins and AI to Revolutionize Structural Heart Planning
GENT, Belgium–(BUSINESS WIRE)–FEops strengthens its position as the cloud-based digital health player in the structural heart space by introducing Artificial Intelligence into its CE marked FEops HEARTguide platform. FEops HEARTguide is a one-in-its-kind procedure planning platform for structural heart interventions that provides physicians with unique insights to evaluate device sizing and positioning pre-operatively. The […]
Varian Receives FDA “Breakthrough Device Designation” for its Cardiac Radioablation (CRA) System for Treatment of Refractory Ventricular Tachycardia (VT)
– Varian’s CRA system has been designated a “breakthrough device” by the FDA because of its potential to offer a more effective treatment for select patients with refractory VT. – Technology being developed will be assessed in clinical studies as a noninvasive treatment for select patients with refractory VT. PALO […]
Mezzion’s New Drug Application (“NDA”) for its Orphan Drug Udenafil for the Treatment of Single Ventricle Heart Disease (“SVHD”) has been Accepted for Filing by the FDA
SEOUL, South Korea, May 25, 2021 /PRNewswire/ — Mezzion Pharma Co., Ltd. (140410.KQ) is pleased to announce today that it has received notice from the FDA that its NDA submitted on March 26, 2021 for the use of udenafil to treat SVHD patients who have undergone Fontan palliation is sufficiently complete to permit a substantive review […]
Foldax Announces Successful First Human Use of Tria Biopolymer Mitral Heart Valve
Second Product from Tria Biopolymer Valve Portfolio to Move into Human Study SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced the successful first-in-human use of its biopolymer Tria™ heart valve in surgically replacing a diseased mitral valve. The first case was performed by David Heimansohn, MD, at Ascension St. Vincent Hospital, […]



