Author: Ken Dropiewski

MyoKardia Announces Design of Phase 3 EXPLORER-HCM Study Evaluating Mavacamten in Symptomatic, Obstructive Hypertrophic Cardiomyopathy

SOUTH SAN FRANCISCO, Calif., May 21, 2018 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq:MYOK), a clinical-stage biopharmaceutical company pioneering a precision medicine approach for the treatment of heritable cardiovascular diseases, today announced the design of its pivotal Phase 3 EXPLORER-HCM clinical trial to evaluate the use of mavacamten for the potential […]

FlowTriever System from Inari Medical Receives FDA 510(k) Clearance for Treatment of Pulmonary Embolism

IRVINE, Calif., May 21, 2018 /PRNewswire/ — Inari Medical, Inc., announced today the FlowTriever System has received FDA 510(k) clearance for the treatment of pulmonary embolism (“PE”). This clearance makes the FlowTriever System the first and only thrombectomy device cleared by the FDA for the treatment of PE.   The PE-specific clearance was based […]

Edwards Announces Key Events For EuroPCR 2018

PARIS, May 21, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced key events for the company during EuroPCR 2018, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of […]

CERENOVUS Receives FDA Clearance For Next Generation Stent Retriever Device Used To Treat Ischemic Stroke

IRVINE, Calif., May 21, 2018 /PRNewswire/ — CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EMBOTRAP II Revascularization Device, a next generation stent retriever used to capture and remove life-threatening blood clots from […]

CellAegis Announces Completion of Patient Enrollment in Danish Investigator Sponsored Clinical Trial Using autoRIC® Device

TORONTO, May 17, 2018 (GLOBE NEWSWIRE) — CellAegis Devices Inc. (“CellAegis” or the “Company”), a commercial-stage medical device company advancing innovative, non-invasive, safe and cost-effective solutions for acute and chronic cardiovascular conditions, today announced completion of patient enrollment in a large scale, investigator sponsored trial (“CONDI 2”) to further assess […]

Correvio Announces Enrollment of First Patient in Phase 3 Study Evaluating Brinavess® in China

VANCOUVER, May 17, 2018 /PRNewswire/ – Correvio Pharma Corp. (NASDAQ: CRME / TSX: COM), formerly Cardiome Pharma Corp., today announced that its partner Eddingpharm has enrolled the first patient in a randomized, double-blind, placebo-controlled, Phase 3 clinical study evaluating Brinavess® versus placebo in patients with recent onset atrial fibrillation (AF).  Approximately 240 patients are expected […]

Teleflex to Introduce the New TrapLiner® Catheter in Europe and Showcase the Arrow® AC3 Optimus™ Intra-Aortic Balloon Pump (IABP) at the European Association for Percutaneous Cardiovascular Interventions Course (EuroPCR) 2018

WAYNE, Pa.–(BUSINESS WIRE)–Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care, urology and surgery, coronary and peripheral interventions, will showcase its complex PCI product portfolio and the Arrow® AC3 Optimus™ Intra-Aortic Balloon Pump (IABP) at the EuroPCR being held in Paris, France on May 22 – […]