CARMAT announces it has received the approval to perform, within the framework of the PIVOTAL study protocol approved by the ANSM (French national agency for the safety of medicines and health products),
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 announces it has received the approval to perform, within the framework of the PIVOTAL study protocol approved by the ANSM (French national agency for the safety of medicines and health products), implants of its total artificial heart in patients at the Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.
The IKEM is particularly recognized for its scientific research and its pioneering role in adopting the latest innovations in the field of medical devices. Its Department of Cardiovascular Surgery is a leading unit in the field of cardiac surgery with the longest tradition of end-stage heart failure therapy in the Czech Republic with the first heart transplantation done in 1984. Nowadays it is recognized as one of the leading centers in Central Europe given its expertise in advanced heart failure therapies.
Professor Ivan Netuka, a Chair of the Department of Cardiovascular Surgery, IKEM, comments: “At the year of the 50th anniversary of the first human heart transplantation, we are particularly enthusiastic to join the mission of evaluating the CARMAT artificial heart. The device offers an innovative approach to the treatment of advanced heart failure given its unique autonomous control and hemocompatibility features. We are delighted to participate in the project which aims to address an unmet need for patients suffering from severe and irreversible cardiac conditions.”
Stéphane Piat, CEO of CARMAT, adds: “With the association of the Czech Republic to our clinical strategy, we now have three countries in our PIVOTAL study. Our goal is to access international centers that have significantly contributed to the success of clinical studies in the field of mechanical assistance. I am therefore delighted to count on the support of the Astana and Prague centers, which have been among the most active hospitals in LVAD studies in Europe. These two new partnerships will enable us to optimize the recruitment for our study, both qualitatively and quantitatively. We have also initiated the administrative procedures in 4 other countries in order to expand the network of participating centers within the study in the upcoming months.”
●●●
About CARMAT: the world’s most advanced total artificial heart project
A credible response to end-stage heart failure: CARMAT aims to eventually provide a response to a major public health issue associated with heart disease, the world’s leading cause of death: chronic and acute heart failure. By pursuing the development of its total artificial heart, CARMAT intends to overcome the well-known shortfall in heart transplants for the tens of thousands of people suffering from irreversible end-stage heart failure, the most seriously affected of the 20 million patients with this progressive disease in Europe and the United States.
The result of combining two types of unique expertise: the medical expertise of Professor Carpentier, known throughout the world for inventing Carpentier-Edwards® heart valves, which are the most used in the world, and the technological expertise of Airbus Group, world aerospace leader.
Imitating the natural heart: given its size, the choice of structural materials and its innovative physiological functions, CARMAT’s total artificial heart could, assuming the necessary clinical trials are successful, potentially benefit the lives of thousands of patients a year with no risk of rejection and with a good quality of life.
A project leader acknowledged at a European level: with the backing of the European Commission, CARMAT has been granted the largest subsidy ever given to an SME by Bpifrance; a total of €33 million.
Strongly committed, prestigious founders and shareholders: Airbus Group (Matra Défense), Professor Alain Carpentier, the Centre Chirurgical Marie Lannelongue,Truffle Capital, a leading European venture capital firm, ALIAD, Air Liquide’s venture capital investor, CorNovum, an investment holding company held 50-50 by Bpifrance and the French State, the family offices of Pierre Bastid (ZAKA) and of Dr. Antonino Ligresti (Santé Holdings S.R.L.) as well as the thousands of institutional and individual shareholders who have placed their trust in CARMAT.
For more information: www.carmatsa.com
