Coronary/Structural Heart

CARMAT: Continuing Progress in Line with the Objective of Obtaining CE Marking in 2019

PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced an update on the progress of the PIVOTAL study and the latest developments regarding […]

Abiomed (ABMD) Reports European Approval (CE Marking) for Impella 5.5 & 1st Patient Treated at University Heart Center Hamburg

Abiomed, Inc. (NASDAQ: ABMD) announced today that the Impella 5.5™ heart pump received CE marking1 approval in Europe and the first patient was treated at University Heart Center in Hamburg, Germany. The Impella 5.5 heart pump further enhances Abiomed’s product portfolio and provides physicians a 30-day, ambulatory, wean-able, forward flow heart pump. […]

Paragonix Technologies, Inc. Announces Presentation of the SherpaPak™ Cardiac Transport Systems and SherpaPerfusion™ Cardiac Transport System at the 38th Annual Meeting of the International Society for Heart and Lung Transplantation

BRAINTREE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc. will present the SherpaPak™ Organ Transport product line at Booth 14 during the 38th Annual Meeting of the International Society for Heart and Lung Transplantation (ISHLT) (Nice, France, 11-14 April 2018). The SherpaPak™ Organ Transport product line1,2 combines innovative cooling technology with safe, consistent methods for cold […]

Transradial Access Market 2018 – Global Forecast 2022: Becton, Dickinson and Company (US) and Terumo Dominated the Market in 2017 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Transradial Access Market by Product (Catheters, Guidewires, Sheath and Sheath Introducers), Application (Administration of Medicine and Administration of fluids), End User (Hospitals, Clinics & Ambulatory Centres) – Global Forecast 2022” report has been added to ResearchAndMarkets.com’s offering. The Global Transradial Access Devices Market is Expected to Grow at a CAGR of 7.5% […]

FDA Approves GORE® CARDIOFORM Septal Occluder for PFO Closure to Prevent Recurrent Ischemic Stroke

FLAGSTAFF, Ariz., April 3, 2018 /PRNewswire/ — Following the unprecedented Gore REDUCE Clinical Study conclusion that closure of patent foramen ovale (PFO) can prevent recurrent ischemic strokes, W. L. Gore & Associates, Inc. (Gore) has received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication for its GORE® CARDIOFORM Septal Occluder. The device, already […]

Abiomed Receives FDA Approval for Impella CP® with SmartAssist™ and Optical Sensor

DANVERS, Mass., April 02, 2018 (GLOBE NEWSWIRE) — Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, announced today that it has received U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its Impella CP®heart pump with SmartAssistTM, utilizing an optical sensor. At the forefront […]

Northwestern Memorial Hospital Surgeon First in Illinois to Repair Aortic Valve with Novel Ring

CHICAGO, March 29, 2018 /PRNewswire/ — A Northwestern Memorial Hospital cardiac surgeon helped pioneer the use of an U.S. Food and Drug Administration (FDA) approved aortic valve ring as part of a triple valve repair, the first of its kind in the United States. S. Chris Malaisrie, MD, has performed two successful surgeries using the […]

Marketwired: Mar 29, 2018 — Novoheart Files Patent Application on Disease Modeling Based on Landmark Research Conducted During Second Contract with Global Pharma Partner

VANCOUVER, BRITISH COLUMBIA — (Marketwired) — Mar 29, 2018 — Novoheart (“Novoheart” or the “Company”) (TSX VENTURE: NVH)(FRANKFURT: 3NH) is pleased to announce that it has filed a patent application on the use of its proprietary MyHeart™ Platform of human bioengineered heart tissues to create disease models for neurological diseases in which […]

Corvidia Therapeutics Appoints Marc de Garidel as Chief Executive Officer

WALTHAM, Mass.–(BUSINESS WIRE)– Corvidia Therapeutics Inc., a leading clinical stage biotechnology company, today announced the appointment of Marc de Garidel as Chief Executive Officer. Mr. de Garidel succeeds Corvidia’s Michael Davidson, M.D., who will remain on the company’s executive team as Chief Scientific Officer. “As we transition from a clinical stage […]

LivaNova Bicarbon Aortic Valves Receive CE Mark for Expanded Use Labeling with Lower-Dose Blood Thinners in Low-Risk Patients

LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, has received CE Mark approval for its Bicarbon® aortic valves for use with low-dose anticoagulant therapy. The expanded CE labeling means that a lower international normalized ratio (INR), the standardized index used to measure blood coagulability, can be […]