DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces the United States Food and Drug Administration (FDA) has approved the company’s investigational device exemption application to start an early feasibility study with a first-in-human trial of the 9 French (Fr) Impella ECP™ heart pump. Impella ECP, which stands for expandable cardiac power, will be […]
Coronary/Structural Heart
Edwards SAPIEN 3 Transcatheter Heart Valve Receives Approval In China
IRVINE, Calif., June 8, 2020 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has received Chinese regulatory approval for the Edwards SAPIEN 3 transcatheter heart valve for the treatment of patients suffering from severe, symptomatic aortic […]
Medtronic Resolute Onyx™ DES Receives First and Only One-Month DAPT Indication for High Bleeding Risk Patients in Europe
DUBLIN, June 05, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received CE (Conformité Européenne) Mark for a one-month dual antiplatelet therapy (DAPT) indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx™ Drug-Eluting Stent (DES). For HBR patients, whose bleeding risk may be increased by taking longer DAPT […]
Mynomx Announces Scientific Validation of Its Cardiometabolic Risk Engines for Assessing Risk of COVID-19 in Populations
PALO ALTO–(BUSINESS WIRE)–Mynomx Inc. (formerly Precision Wellness, Inc.), a Silicon Valley-based company at the intersection of next-generation AI analytics and the latest medical and nutrition science, today announced the scientific validation of their cardio and metabolic predictive models against 2.5M patient population through two sponsored research studies with Stanford University. […]
MedHub AutocathFFR Awarded AMAR Certification, Israel’s Medical Device Regulatory Approval
AutocathFFR, the company’s first commercial product, is a transformative cardiac diagnosis system. TEL AVIV, Israel, June 4, 2020 /PRNewswire/ — MedHub Ltd., a medical technology company focused on developing and commercializing AI powered medical solutions that aid in the diagnosis of cardiac disease, announced that is has gained AMAR approval for its […]
Esperion Announces Commercial Availability of NEXLIZET™ (bempedoic acid and ezetimibe) Tablets and Ushers in New Era of Oral Combination Medicine for LDL-Cholesterol Lowering
– First-Ever Non-Statin Combination Medicine, Providing 38 Percent Mean LDL-C Lowering – – Esperion Aims to Set New Industry Standard by Pricing NEXLIZET for Patient Affordability and Access with Minimal to No Paperwork Requirements for Health Care Providers – – Launch Date Accelerated by One Month at Health Care Providers Request […]
Neovasc Reducer Spotlighted in Leading German Public Television Program
Elective Interventional Procedures Resume in Germany VANCOUVER and MINNEAPOLIS, MN, June 03, 2020 (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 minimally invasive devices for the treatment of refractory angina, today announced […]
Heart Valve Voice Canada Calls for the Prioritization of Heart Valve Disease Patients as Elective Surgeries Begin to Resume
TORONTO, June 03, 2020 (GLOBE NEWSWIRE) — Heart Valve Voice (HVV) Canada, a non-profit patient advocacy organization for those with heart valve disease, urges provincial governments and health care institutions to prioritize the treatment of heart valve disease patients as elective surgeries are reassessed and begin to resume during COVID-19. […]
Teleflex Announces First Patient Enrollment in CTO-PCI IDE Study
Study Will Evaluate the Performance of Teleflex Coronary Guidewires and Specialty Catheters in Patients Undergoing Chronic Total Occlusion Percutaneous Coronary Interventions WAYNE, Pa., June 02, 2020 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the first patient enrollment in a clinical study […]
CeloNova Announces Enrollment Completion of World’s First Randomized Control, 14-Day DAPT Trial
First-of-its-kind study evaluates ultra-short DAPT in PCI patients at high bleeding risk compared to drug-eluting stents SAN ANTONIO, June 1, 2020 /PRNewswire/ — CeloNova BioSciences, Inc. (CeloNova), a global medical device company that offers a family of innovative products based upon its proprietary Polyzene™-F nanocoating technology, today announced that it has successfully completed enrollment […]



