Coronary/Structural Heart

BIOLIFE4D CSO Dr. Ravi Birla Publishes Paper in Prestigious APL Bioengineering Scholarly Journal

Birla co-published paper with Stuart K. Williams, a renowned industry figure, to highlight 3D bioprinting’s impact on cardiac failure treatment CHICAGO, Feb. 27, 2020 (GLOBE NEWSWIRE) — BIOLIFE4D, a biotech pioneer leveraging advances in tissue engineering to 3D print human organs viable for transplant, today announced its Chief Science Officer, Dr. […]

Esperion Announces FDA Approval of the NEXLIZET™ (bempedoic acid and ezetimibe) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine

– NEXLIZET Lowered LDL-C by 38 Percent Compared to Placebo when Added on to Maximally Tolerated Statins – – First Non-Statin, LDL-Cholesterol Lowering Combination Medicine Ever Approved – – Esperion’s Second Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine Approved in the U.S. Following NEXLETOL™ (bempedoic acid) Tablet Approval on February 21, […]

Otitopic Advances Asprihale® Into Pivotal PK/PD Study

Asprihale® is intended for emergency treatment to reduce the risk of vascular mortality in patients with suspected acute myocardial infarction (MI). LOS ANGELES–(BUSINESS WIRE)–Otitopic today announces that it is advancing towards its pivotal PK/PD study following discussions with the FDA. The randomized pivotal study, which is expected to initiate in the […]

Amgen, Cytokinetics And Servier Announce Continuation Of GALACTIC-HF Following Planned Interim Analysis

Data Monitoring Committee Recommends Phase 3 Clinical Trial of Omecamtiv Mecarbil in Patients with Heart Failure Continue without Changes Topline Results Expected in Q4 2020 THOUSAND OAKS, Calif., SOUTH SAN FRANCISCO, Calif., and SURESNES, France, Feb. 26, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN), Cytokinetics, Incorporated (NASDAQ:CYTK) and Servier today announced that the Data Monitoring Committee (DMC) […]

Foldax Tria LifePolymer Heart Valve Technology Honored with Best Innovation Award at 2020 Cardiovascular Research Technologies Meeting

SALT LAKE CITY–(BUSINESS WIRE)–Foldax® announced today that Tria LifePolymer™ heart valve technology was honored with The Best Innovation Award at the 2020 Cardiovascular Research Technologies (CRT) meeting in National Harbor, MD. The presentation, titled “Foldax Tria First in Human Implant of a Totally Synthetic Polymeric Aortic Heart Valve,” was given […]

PhysIQ and U.S. Veteran’s Affairs Publish Breakthrough Study Predicting Heart Failure Hospitalization up to 10 days in Advance using AI

PhysIQ and the U.S. VA publish results of a clinical trial that demonstrates how artificial intelligence (AI) applied to continuous wearable sensor data may predict hospitalizations. When coupled with the high sensor wear compliance rates, the 7-10-day early warning timeframe suggests this approach has great promise to reduce hospitalization and […]

New Data Confirms Cardiac Dimensions’ Carillon® System Shows Favorable Long-Term Survival Rate In Patients With Functional Mitral Regurgitation

Pooled Analysis of Prospective Studies Presented during Late Breaking Trials Session at CRT 2020 KIRKLAND, Wash., Feb. 25, 2020 /PRNewswire/ — Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure (HF), today announced the findings of a post hoc analysis of […]

BIOTRONIK’s Ultrathin Strut Orsiro Coronary Drug-Eluting Stent Continues to Deliver Excellent Results After Three Years

Data from BIOFLOW-V Trial Presented at CRT and Published in JACC: Cardiovascular Interventions Reinforces Orsiro’s Ability to Outperform Abbott’s Xience NATIONAL HARBOR, Md., Feb. 24, 2020 /PRNewswire/ — BIOTRONIK today announced three-year data from the BIOFLOW-V trial, which was presented yesterday at the 2020 CRT Congress. The three-year follow-up data demonstrates consistently lower clinical […]

Edwards Lifesciences’ Every Heartbeat Matters Philanthropic Initiative Expanding To Reach More Patients

IRVINE, Calif., Feb. 21, 2020 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced a new goal for its philanthropic initiative, Every Heartbeat Matters (EHM): to improve the lives of 2.5 million additional underserved structural heart and critical care patients by the end […]

Cardiovalve Receives ‘Breakthrough Device Designation’ for Its Transcatheter Tricuspid Valve Replacement System

Cardiovalve becomes first privately held company to receive FDA’s early feasibility study (EFS) approval for both tricuspid regurgitation (TR) and mitral regurgitation (MR) indications OR YEHUDA, Israel–(BUSINESS WIRE)–Cardiovalve announced today that it has received U.S. Food and Drug Administration (FDA) approval for an Early Feasibility Study (EFS) of its Transcatheter Tricuspid Valve […]