Coronary/Structural Heart

CorMatrix® Cardiovascular, Inc. receives FDA IDE approval to conduct the safety and feasibility clinical trial of the Cor™ TRICUSPID ECM® valve for pediatric and adult patients

ATLANTA, Jan. 24, 2019 /PRNewswire/ — CorMatrix® Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, today announced FDA approval of an early feasibility study IDE to evaluate the safety and feasibility of the Cor™ TRICUSPID ECM® cardiac valve for adults with endocarditis and for pediatric patients with congenital heart valve disease. The […]

Paragonix Technologies Announces Presentation of the Paragonix SherpaPak™ Cardiac Transport System at the 55th Society of Thoracic Surgeons Annual Meeting

BRAINTREE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc. will present the Paragonix SherpaPak™ Cardiac Transport System product line at Booth 924 during the 55th Annual Meeting of the Society of Thoracic Surgeons (STS) held in San Diego, from January 27 to January 29, 2019. The Paragonix SherpaPak™ CTS is the only FDA cleared and CE marked […]

New REDUCE-IT™ Trial Data Showing the Total Reduction in Ischemic Events Accepted for Presentation at the American College of Cardiology’s 68th Annual Scientific Session

BEDMINSTER, N.J., and DUBLIN, Ireland, Jan. 23, 2019 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on improving cardiovascular health, announced that new data showing the reduction in total major adverse cardiovascular (i.e., ischemic) events shown in the landmark REDUCE-IT™ cardiovascular outcomes trial has been accepted for […]

Neovasc announces peer reviewed publication in JACC demonstrating objective evidence of improvement in perfusion after Reducer implantation

VANCOUVER, Jan. 23, 2019 /PRNewswire/ – Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ: NVCN)(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, today announced that the Journal of the American College of Cardiology: […]

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 […]