Coronary/Structural Heart

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, […]

JenaValve Technology Receives CE Mark for its Trilogy™ TAVI System for the Treatment of Aortic Regurgitation and Aortic Stenosis

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 […]

Emboline Raises over $55 Million in Series D Funding for Pivotal FDA Clinical Study and Market Launch of the Emboliner™ Embolic Protection Catheter to Minimize Stroke Risk from TAVR

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 […]

Procyrion Announces Successful First-in-Human Cases in Cardiorenal Syndrome (CRS) Patients with Aortix™ Percutaneous Mechanical Circulatory Support Device

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 […]

Liquidia Announces Generic Treprostinil Injection Now Also Available for Subcutaneous Route of Administration

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 […]

Paragonix Partners With Southwest Transplant Alliance to Provide Advanced Organ Preservation

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Paragonix Technologies announced a partnership with Southwest Transplant Alliance (STA) to provide advanced organ preservation technology as part of both organization’s ongoing work to save lives through organ donation and transplantation. Under this new partnership, Paragonix will provide the technology, clinical support and education on the advanced preservation capabilities delivered by […]

Confluent Medical Technologies Expanding, Adding Capacity for Nitinol Processing and Catheter Manufacturing

Confluent Medical Technologies Announces Expansion of the Confluent Costa Rica Manufacturing Location To Meet Growing Demand in Nitinol Processing & Specialized Catheters SCOTTSDALE, Ariz.–(BUSINESS WIRE)–Confluent Medical Technologies (Confluent), today announced a significant expansion of their Costa Rica manufacturing by adding a new facility to accommodate the increase in customer demand […]