Coronary/Structural Heart

FDA Grants Breakthrough Device Designation Status for BioVentrix Revivent TC Transcatheter Ventricular Enhancement System for Heart Failure

SAN RAMON, Calif.–(BUSINESS WIRE)–BioVentrix, Inc., a privately-held company with a first-in-class, transcatheter-based structural heart device to treat heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation status for its Revivent TC™ Transcatheter Ventricular Enhancement System for heart failure. Less Invasive […]

Prevencio Announces Highly Accurate, AI-driven Blood Test with High Sensitivity (hs) Cardiac Troponin for the Diagnosis of Heart Disease

HART CADhs test addresses up to 30% of Emergency Department (ED) chest pain patients who cannot safely be ruled-in nor ruled-out for heart attack KIRKLAND, Wash.–(BUSINESS WIRE)–Prevencio, Inc. today announces data confirming the high accuracy of its AI-driven, multiple-protein HART CADhs test, a biomarker clinical/proteomic panel inclusive of high sensitivity cardiac […]

Neovasc Tiara™ Progress Highlighted at PCR London Valves 2019

VANCOUVER, Nov. 19, 2019 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, announced that its transfemoral trans-septal (“TF/TS”) Tiara™ […]

Amarin Highlights Key REDUCE-IT®-Related Data Presented at American Heart Association 2019 Scientific Sessions

REDUCE-IT USA results, in prespecified subgroup analyses, showed cardiovascular risk reductions across all endpoints, including 30% relative risk reduction  in all-cause mortality New analysis determined icosapent ethyl (Vascepa®) is highly cost-effective in patients from the REDUCE-IT study and, as is rarely found, may result in net healthcare cost-savings to patients, payers […]

Faraday Pharmaceuticals Announces Positive Top-Line Results from Phase 2 Trial of FDY-5301 for Treatment of Reperfusion Injury Following a STEMI Heart Attack

Treatment well tolerated, with encouraging signs to support pivotal trial Results presented at American Heart Association Scientific Sessions 2019 SEATTLE, Nov. 19, 2019 /PRNewswire/ — Faraday Pharmaceuticals, a biopharmaceutical company focused on the development of small molecules for critical care medicine, today announced top-line results from its Phase 2 trial of FDY-5301 for […]

Clinical Review Demonstrates Cost-Effectiveness of Impella in High-Risk PCI and Cardiogenic Shock

DANVERS, Mass.–(BUSINESS WIRE)–To mark the five year anniversary of the study by Stretch, et al., on cost and outcomes trends for short-term mechanical circulatory support, Abiomed announces a comprehensive publication review of cost and comparative effectiveness of Impella in high-risk PCI and cardiogenic shock. The data, from a robust body of US and European […]

Amgen Announces New FOURIER Analysis Showing Benefit Of Repatha® (evolocumab) In High-Risk Patients Who Have Experienced A Recent Heart Attack

Additional FOURIER Analysis Shows Lowering LDL-C With Repatha Did Not Impair Patient-Reported Cognition THOUSAND OAKS, Calif., Nov. 16, 2019 /PRNewswire/ — Amgen today announced a new analysis from the Repatha® (evolocumab) cardiovascular outcomes (FOURIER) study that evaluates the effectiveness of Repatha in patients who have suffered a recent myocardial infarction (MI). The analysis showed […]

Endotronix Announces Positive Data from the SIRONA First-in-Human Trial for the Cordella™ PA Pressure Sensor System

Data presented at the 2019 American Heart Association Scientific Sessions LISLE, Ill., Nov. 18, 2019 /PRNewswire/ — Endotronix, a digital health and medical technology company dedicated to advancing the treatment of chronic heart failure (HF), presented positive first-in-human data of the Cordella™ Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor). Data was […]

Janssen Leverages Wearable Technology to Reimagine Clinical Trial Design

CHIEF-HF is the first-ever completely decentralized, mobile, indication-seeking study assessing effectiveness of INVOKANA® (canagliflozin) in adults with heart failure (HF), with or without type 2 diabetes (T2D) Company tests innovative trial design with potential to bring medicines to patients faster and more cost-effectively TITUSVILLE, N.J., Nov. 16, 2019 /PRNewswire/ — The Janssen Pharmaceutical […]

Novartis PARAGON-HF analyses suggest Entresto® benefit beyond HFrEF

Entresto (sacubitril/valsartan) demonstrated greatest benefit in HFpEF patients with ejection fractions adjacent to HFrEF, compared to valsartan1 Entresto, compared to valsartan, demonstrated reduced risk in total heart failure hospitalizations and cardiovascular death in women, compared to men2 Among patients who had been previously hospitalized, those who were screened during or […]