The first human implantations of bioprosthetic artificial hearts
CARMAT, the designer and developer of the world’s most advanced project of total artificial heart, announces today that it has obtained the approval of four renowned international cardiac surgery centers in Belgium, Poland, Saudi Arabia and Slovenia to proceed with the first clinical implantations of its bioprosthetic total artificial heart.
These institutions are the St Pierre University Hospital (Brussels, Belgium), the Silesian Center for Heart Disease (Zabrze, Poland), the Prince Sultan Cardiac Center (Riyadh, Saudi Arabia), and the University Medical Centre Ljubljana (Ljubljana, Slovenia).
All these institutions share excellence in surgical results and heart patient care, depth of patient recruitment and experience in innovative medical devices pre-market clinical trials.
In a common statement, Prof. Didier de Cannière, Chief of the Department of Cardiac Surgery at St Pierre University Hospital in Brussels, Belgium, Prof. Marian Zembala, Chairman, Department of Cardiac Surgery and Transplantation and Director of the Silesian Center for Heart Diseases in Zabrze, Poland, Prof. Borut Geršak, Head of the Department of Cardiovascular Surgery at the Ljubljana University Medical Centre, in Ljubljana, Slovenia, and Prof. Antonio Calafiore, Head of the Department of Adult Cardiac Surgery at Prince Sultan Cardiac Center in Riyadh, Saudi Arabia, declared: “We are very glad to share our experience and knowledge and thus contribute to this extraordinary project, as end-stage heart failure is indeed an international health issue. CARMAT’s bioprosthetic artificial heart could bring true innovation to the heart failure surgical community and we are looking forward to starting its implantation and to exploring its potential benefits for our patients.”
Prof. Alain Carpentier, co-founder and Scientific Director at CARMAT, comments: "I have been very pleased to learn that the leaders of these prestigious departments are willing to join us in the evaluation of the Carmat bioprosthesis. As recognized experts in the field, they will be able to appreciate first-hand the unique features and remarkable performances of this prosthesis."
Marcello Conviti, CEO of CARMAT, concludes: “The patient selection process and the training of the clinical teams are ongoing in these four countries, supported by our French proctors, Prof. Christian Latrémouille, Cardiac Surgeon at the Georges Pompidou European Hospital in Paris and Prof. Daniel Duveau, Medical Director of the Thorax Institute and of the Department of Thoracic and Vascular surgery at University Hospital in Nantes. Implantations could start shortly following the completion of the training. Carmat expects to receive additional approvals in a near future, potentially in France (ANSM approval) and in other countries.”
About CARMAT, the world’s most advanced total artificial heart project
The only credible response for all cases of end-stage heart failure, which is a real public health issue: CARMAT’s aim is to be able to 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. Indeed, this disease currently affects over 100 million patients in developed countries. 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 heart failure.
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 EADS, 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 upcoming clinical trials are successful, potentially benefit the lives of tens of thousands of patients a year whilst ensuring there is no risk of rejection and providing them with an unparalleled 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 OSEO; a total of €33 million.
Strongly committed, prestigious founders and shareholders: Truffle Capital, a leading European venture capital firm, EADS, the Fondation Alain Carpentier, the Centre Chirurgical Marie Lannelongue, and the thousands of institutional and individual shareholders who have placed their trust in CARMAT.
For more information: www.carmatsa.com
14.05.2013
