PARIS, 20 February 2018 – CARMAT (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 Heart Center of the Rigshospitalet hospital, Copenhagen, Denmark.
The Heart Center of the Rigshospitalet is an internationally recognized center for the diagnosis and treatment of all types of heart diseases. It has developed a strong expertise in treating advanced heart failure and has participated in front-line clinical studies with innovative medical therapies and devices in this field. The study will be conducted by Professor Finn Gustafsson, a leading heart failure and transplantation cardiologist whose research focuses on the use of invasive hemodynamics in patients.
Finn Gustafsson, MD, PhD, Professor of Advanced Heart Failure and Transplantation at the Heart Center and principal investigator of the study, comments: "As advanced heart failure and mechanical circulatory support is my main area of expertise, I am excited to evaluate the CARMAT artificial heart for the treatment of end-stage heart-failure patients. With its self-regulation and hemocompatibility, this device could potentially offer a real alternative to heart transplant."
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Stéphane Piat, CEO of CARMAT, adds: "I am delighted that, shortly after Astana and Prague, the Heart Center of Copenhagen becomes the third international center to take part in our PIVOTAL study. The experience and enthusiasm of the teams makes us confident in starting patient recruitment shortly. We continue to pursue our strategy of creating a pool of highly specialized centers particularly recognized for their know-how in LVAD[1] studies and we expect to include three more centers in the upcoming months. This should allow us to sustain the patient enrollment pace in line with our objective of finalizing the PIVOTAL study by the end of this year."
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.
