The Latest Cardiac and Vascular News
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 […]
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 […]
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’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 […]
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 […]
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, […]
IRVINE, Calif., May 25, 2021 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve implantation (TAVI) systems (also referred to as TAVR, or transcatheter aortic valve replacement) for the treatment of aortic valve disease, today announced that it has received CE Mark for its TrilogyTM Heart […]
Financing led by Matrix Capital Management with significant investment from an undisclosed strategic investor — Eric Xiao of Matrix Capital Management to join the Emboline Board of Directors SANTA CRUZ, Calif., May 25, 2021 /PRNewswire/ — Emboline, Inc., a privately held medical device company focused on reducing stroke and other damage caused by embolic […]
Pilot CRS Study to Evaluate Performance of Novel Aortix device in Australia and the U.S. HOUSTON, May 25, 2021 /PRNewswire/ — Procyrion, Inc., a medical device company dedicated to improving outcomes for patients with cardiac and renal impairment, announced today successful treatment of the first patients in the company’s pilot trial to evaluate […]
Sandoz Generic Treprostinil Injection now available for both routes of administration, subcutaneous and intravenous MORRISVILLE, N.C., May 24, 2021 (GLOBE NEWSWIRE) — Liquidia Corporation (NASDAQ: LQDA) (“Liquidia” or the “Company”) today announced that Sandoz Treprostinil Injection, a generic form of Remodulin®, is now also available for subcutaneous (“SC”) administration to […]
