Coronary/Structural Heart

New Studies in the U.S. and Europe Demonstrate LivaNova Perceval Valve’s Strong Performance and Economic Advantage in Aortic Disease Treatment

LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today announced the publication of three separate studies highlighting the unique performance of its sutureless aortic valve, Perceval®. The results from the Perceval Aortic Heart Valve Study in North America, performed under a U.S. Food and Drug Administration (FDA) Investigational Device […]

Terumo Introduces Its Smallest, Lowest Prime Volume, Full-Size Adult* Capiox® Oxygenator

ANN ARBOR, Mich., Jan. 16, 2019 /PRNewswire/ — Terumo Cardiovascular Group, a global leader in cardiovascular surgery technologies, today announced the launch of its smallest full-size adult* oxygenator, the Capiox® NX19 Oxygenator with UltraPrime™ Technology. Terumo began sales of the product in the U.S. and Europe, and will expand its sales coverage to Japan and Asia. Through Terumo’s most […]

CARMAT presents positive interim results of the first part of its PIVOTAL study

CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced an update on its clinical progress and recent developments, as well as its cash position at December 31, […]

Microbot Medical Increases its Global IP Portfolio with Notice of Allowance from the European Patent Office

HINGHAM, Mass., Jan. 14, 2019 (GLOBE NEWSWIRE) — Microbot Medical Inc. (NASDAQ: MBOT), received a notification from the European Patent Office that it will grant a patent for Application No. 08738207, which covers the Company’s ViRob™ technology platform. Including this latest notification, the Company has 30 issued/allowed patents and 18 […]

FDA Approves World’s First Device for Treatment of Premature Babies and Newborns with an Opening in Their Hearts (a Common Congenital Defect)

ABBOTT PARK, Ill., Jan. 14, 2019 /PRNewswire/ — Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) approved the Amplatzer Piccolo™ Occluder, the world’s first medical device that can be implanted in the tiniest babies (weighing as little as two pounds) using a minimally invasive procedure to treat patent ductus arteriosus, or […]

Shockwave Initiates U.S. Pivotal Study for Coronary Intravascular Lithotripsy

SANTA CLARA, Calif., Jan. 14, 2019 (GLOBE NEWSWIRE) — Shockwave Medical, Inc., a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, has initiated its U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study – DISRUPT CAD III – for the […]

Matinas BioPharma Announces a Research Evaluation with Top Global Pharma Company Based on Its Proprietary Drug Delivery Platform

BEDMINSTER, N.J., Jan. 10, 2019 (GLOBE NEWSWIRE) — Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical stage biopharmaceutical company, today announced they have signed an agreement with an undisclosed top global pharmaceutical company aimed to evaluate synergistic effects of Matinas’ lipid-nano-crystal (“LNC”) platform delivery technology with their partner’s nucleic acid polymer […]

Amgen Makes All Repatha® (evolocumab) Device Options Available In The US At A 60 Percent Reduced List Price

THOUSAND OAKS, Calif., Jan. 7, 2019 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that as part of the Company’s commitment to improve patient affordability for an innovative biologic medicine for people with high cholesterol who are at risk for heart attacks and strokes, all Repatha® (evolocumab) device options, including the Pre-Filled Syringe and Pushtronex® (on-body infusor […]

Microbot Medical Announces FDA Pre-Submission Milestones for 2019

HINGHAM, Mass., Jan. 07, 2019 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq CM: MBOT) announced today anticipated operational and product milestones, including pivotal pre-clinical study and FDA pre-submission milestones, for 2019. The progress and successful execution of key objectives in 2018, which included, among other things, Microbot’s successful completion of […]

Phase 3 Trial of Mesoblast’s Cell Therapy in Chronic Heart Failure Completes Recruitment

NEW YORK and MELBOURNE, Australia, Jan. 07, 2019 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), world leader in development and commercialization of allogeneic (off-the-shelf) cellular medicines, today announced that it has completed patient recruitment in the events-driven Phase 3 trial of its product candidate Revascor (MPC-150-IM) for advanced chronic heart failure. Mesoblast Chief […]