The 5 successful transplants performed during the PIVOTAL study point to the efficacy of the CARMAT heart for patients waiting for a graft 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 […]
Tag: Carmat
CARMAT Announces the First Implantation of Its Total Artificial Heart in Denmark
This implant, performed at Rigshospitalet in Copenhagen, marks the resumption of the recruitment in the PIVOTAL study and brings the total number of patients to thirteen 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 […]
CARMAT Obtains Approval for the Reimbursement of Its Total Artificial Heart During the US Clinical Feasibility Study
Centers for Medicare & Medicaid Services (CMS) confirms coverage of the device and routine care items and services PARIS–(BUSINESS WIRE)–Regulatory News: 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 […]
CARMAT Confirms the Definitive Approval of its “Forfait Innovation” Dossier by the French National Authority for Health (HAS)
With this favorable opinion, CARMAT will request financing of its device within the framework of a clinical study in France PARIS–(BUSINESS WIRE)–Regulatory News: 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 […]
CARMAT Announces That the Shareholders’ Meeting Has Approved All the Resolutions Supported by the Board of Directors and Issues an Update on Its Activities Within the Context of The COVID-19 Pandemic
PARIS–(BUSINESS WIRE)–Regulatory News: 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, informs its shareholders that the annual general meeting (AGM) of March 30, 2020 was able to deliberate, […]
CARMAT Announces that It Has Achieved Record Individual Support of 2 Years With Its Bioprosthesis
PARIS–(BUSINESS WIRE)–Regulatory News: 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 announces that it has reached a major milestone by achieving record individual support of 2 years […]
CARMAT Confirms the Submission of a “forfait Innovation” Dossier in France and Its Eligibility With Observations Received From the French National Authority for Health (HAS)
PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and developer of the world’s most advanced total artificial heart (TAH), aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, announces that the French National Authority for Health (HAS) has deemed the CARMAT TAH eligible with […]
CARMAT Reports Its 2019 Annual Results and Confirms Its 2020 Objectives
Operating expenses under control in a context of intensifying the European market access strategy Strong cash position of €55.5 million at December 31, 2019, providing financial visibility until mid-2021 Full FDA approval for a clinical feasibility study in the United States, with enrollment expected to begin in the fourth quarter […]
CARMAT Announces FDA Full Approval to Initiate US Clinical Feasibility Study of Its Total Artificial Heart
CARMAT has responded to all remaining questions from the conditional approval Number of subjects to be enrolled in the study extended to 10 patients PARIS–(BUSINESS WIRE)–Regulatory News: 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 […]
CARMAT Appoints Alexandre Eleonore as Director of Manufacturing
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 the appointment of Mr Alexandre Eleonore as Director of Manufacturing. Alexandre Eleonore is a […]