Coronary/Structural Heart

Essential Medical Announces Positive Results From the SAFE MANTA Clinical Trial, the First Pivotal Trial for a Dedicated Large Bore Closure Device

EXTON, Pennsylvania, June 25, 2018 /PRNewswire/ — Essential Medical, Inc., a private medical device company focused on innovative solutions for large bore vascular closure, today announced the results from the SAFE MANTA IDE clinical trial, the first pivotal trial for a dedicated large bore closure device. Dr. David Wood, Co-Principal Investigator and founding […]

REVA Extends Technological Lead in Bioresorbable Scaffolds With CE Mark Approval of the Full Fantom® Encore Product Line

SAN DIEGO, June 18, 2018 (GLOBE NEWSWIRE) — REVA Medical, Inc. (ASX:RVA) (“REVA” or the “Company”), a leader in bioresorbable polymer technologies for vascular applications, today announced it has received CE Mark approval for its full Fantom® Encore product line. This covers Fantom Encore in the 3.0 and 3.5 mm diameters, […]

PlaqueTec Sponsors and Presents Data at Vulnerable Patient Meeting

CAMBRIDGE, England–(BUSINESS WIRE)–PlaqueTec announced today that it will sponsor the exclusive Vulnerable Patient Meeting (VPM), taking place 24-26 June in Stresa, Italy, for the fourth time. VPM, hosted by Cardialysis, is an annual invitation-only meeting focused on atherosclerosis for approximately 75-100 attendees, with a faculty of cardiology opinion leaders, regulators, […]

Idorsia initiates PRECISION – Phase 3 study with aprocitentan for resistant hypertension management

Allschwil, Switzerland – June 20, 2018  Idorsia Ltd (SIX: IDIA) today announced that the first patient has been enrolled into PRECISION, a Phase 3 study to investigate the efficacy and safety of aprocitentan for resistant hypertension management in adults. Hypertension, or high blood pressure, remains the most frequent addressable risk […]

Hancock Jaffe Laboratories Selects Site for First-in-Human VenoValve Study

IRVINE, Calif., June 20, 2018 (GLOBE NEWSWIRE) — Hancock Jaffe Laboratories, Inc. (Nasdaq:HJLI) (Nasdaq:HJLIW), a company specializing in bioprosthetic medical devices to establish improved standards of care for treating cardiac and vascular diseases, today announced that it has selected Fundación Santa Fe de Bogotá (“FSFB”), in Bogota Columbia, as the […]

Neovasc Announces First Implant of a Neovasc Reducer™ in a U.S. Patient

VANCOUVER, June 20, 2018 /PRNewswire/ – Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, today announced the first U.S. patient has been implanted with a Neovasc Reducer™ (the “Reducer”), a CE-Marked medical device for the treatment of refractory […]

JenaValve Technology Implants Initial Patients in CE Mark Study for the Treatment of Severe Aortic Regurgitation with Next-Generation TAVR System

IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced initiation of patient enrollment and implantations associated with the CE Mark study of its next generation JenaValve Pericardial TAVR System using the CoronatixTM Transfemoral Delivery Catheter for the percutaneous treatment of patients […]

IPS HEART, Resident of Johnson & Johnson Innovation, Uses Human Stem Cells for the First Time to Actually Reverse Heart Attack Damage

HOUSTON–(BUSINESS WIRE)–IPS HEART, resident of Johnson & Johnson Innovation, JLABS is pioneering the use of IPS cellular therapy for the replacement of heart tissue after heart attack, heart failure and duchenne cardiomyopathy. Recent results were presented at the 82nd Annual Scientific Meeting of the Japanese Circulation Society showing over 66% […]

Caladrius Receives FDA Regenerative Medicine Advanced Therapy Designation for CD34+ Cell Therapy for Treating Refractory Angina

BASKING RIDGE, N.J., June 19, 2018 (GLOBE NEWSWIRE) — Caladrius Biosciences, Inc. (Nasdaq:CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company with multiple technology platforms targeting select cardiovascular indications and autoimmune diseases, announces today that the U.S. Food and Drug Administration (“FDA”) has granted regenerative medicine advanced therapy (“RMAT”) designation to […]

Zenosense, Inc.: Breakthrough Quantitative MIDS Testing Results

VALENCIA, SPAIN., June 19, 2018 (GLOBE NEWSWIRE) — Zenosense, Inc. (OTC PINK: ZENO) (“Zenosense”, the “Company”), a healthcare technology company focused on the development and commercialization of the MIDS Cardiac™ hand-held technology for the early detection of heart attack at the Point of Care, is pleased to announce that its […]