Coronary/Structural Heart

Occlutech AFR Heart Failure Device Obtains CE Mark Approval

SCHAFFHAUSEN, Switzerland, Sept. 6, 2019 /PRNewswire/ — Occlutech AG announced today that its atrial flow regulator, the Occlutech AFR device, has obtained CE mark approval clearing it for sales on the European CE regulated market. Occlutech AFR is a next generation intra-atrial shunt device, intended to treat heart failure symptoms by decompressing abnormal […]

BIOLIFE4D Becomes First U.S. Company to Successfully Demonstrate Ability to 3D Bioprint a Mini Human Heart

Pioneering biotech company reaches significant milestone, using proprietary bioink to successfully 3D bioprint a mini-heart with full structure of a whole heart, including chambers and ventricles CHICAGO, Sept. 09, 2019 (GLOBE NEWSWIRE) — BIOLIFE4D, a biotech pioneer leveraging advances in tissue engineering to 3D print human organs viable for transplant, today […]

Two new Pfizer-coauthored studies validate Novoheart’s pioneering human bioengineered heart tissues and chambers for improving drug development

September 09, 2019 00:05 ET | Source: Novoheart Holdings Inc. Novoheart seeks to revolutionize human heart tissue engineering for disease modeling and drug discovery Peer-reviewed publications feature results from the completion of two research contracts between Novoheart and Pfizer Novoheart’s proprietary MyHeartTM Platform of human bioengineered heart tissues can represent healthy as well as […]

Recardio’s Phase 2 Regenerative Post-Myocardial Infarction Trial of Dutogliptin Now Enrolling and Recruiting in All Global Centers

Recardio Inc., a life science company developing regenerative therapies for cardiovascular diseases, announced that its Phase 2 study of dutogliptin in combination with filgrastim in early recovery post-myocardial infarction is now enrolling and recruiting in all multiple European and U.S. centers. SAN FRANCISCO, Sept. 9, 2019 /PRNewswire/ — The clinical study is intended […]

Acceleron Receives FDA Orphan Drug Designation for Sotatercept in Pulmonary Arterial Hypertension

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug designation to sotatercept for the treatment of patients with pulmonary […]

NobleStitch™ EL Receives Approval Of IDE To Conduct A Trial For Reduction Of Recurrent Ischemic Stroke

NOBLES MEDICAL TECHNOLOGIES II, INC. (NMT2) ANNOUNCED TODAY THE APPROVAL BY THE U.S. FDA OF ITS IDE OF NOBLESTITCH™ EL FOR PFO CLOSURE FOR REDUCTION OF RECURRENT ISCHEMIC STROKE FOUNTAIN VALLEY, Calif., Sept. 5, 2019 /PRNewswire/ — Nobles Medical Technologies II has received approval from the U.S. Food and Drug Administration (USFDA) […]

Abbott Launches World’s First Pivotal Trial to Test New Approach for Repairing Leaky Tricuspid Heart Valves

– TRILUMINATE Pivotal trial is the world’s first randomized clinical trial to evaluate transcatheter tricuspid valve repair in patients with severe tricuspid regurgitation – There are currently no approved transcatheter tricuspid repair treatments, limiting options for patients with leaky tricuspid valves who are at high risk for surgery – Abbott’s […]

Esperion Completes Patient Enrollment in the Global CLEAR Cardiovascular Outcomes Trial for Bempedoic Acid

– 14,032 Patients are Now Fully Enrolled in the CLEAR Cardiovascular Outcomes Trial – – Expect CLEAR Cardiovascular Outcomes Trial to Conclude in the Second Half of 2022 – ANN ARBOR, Mich., Sept. 05, 2019 (GLOBE NEWSWIRE) — Esperion (NASDAQ:ESPR) today announced the completion of patient enrollment in the CLEAR […]

Shockwave Receives FDA Breakthrough Device Designation for the Coronary IVL System

SANTA CLARA, Calif., Sept. 03, 2019 (GLOBE NEWSWIRE) — Shockwave Medical, Inc., a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, today announced that the company has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Shockwave […]