French biotech Carmat has obtained the approval of four international cardiac surgery centers in Belgium, Poland, Saudi Arabia, and Slovenia to proceed with the first clinical implantations of its bioprosthetic total artificial heart.
“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,” the heads of the cardiac surgery centers said in a joint statement.
A heart transplant is the solution of last resort for patients with severe heart failure, who have exhausted all other treatment options. Heart transplants from human to human have become fairly commonplace since Dr. Christiaan Barnhard performed the first human heart transplant in South Africa almost 46 years ago, with about 3,500 procedures performed each year. Though there are more than 100,000 awaiting a heart transplant, there are fewer than 4,000 donor hearts available each year.
Carmat’s bioartificial heart was developed over the past 20 years by heart surgeon Alain Carpentier, co-founder and scientific director at Carmat, and the technological expertise of EADS, a global aerospace company. Made of biologic and synthetic polymers, it has the shape, volume, and weight of a human heart that is implanted in the body. It is connected to a portable power source and monitoring system outside of the body. Because it is artificial, the device does not carry the risk of failure due to rejection.
CEO Marcello Conviti says he expects to receive additional approvals to conduct implantations at other sites in the near future, potentially in France and other countries. The company has received $42.7 million (€33 million) to date from OSEO, a public French organization supporting innovation. The company says it is the largest subsidy given to an enterprise of their size by the funding group. Shareholders in Carmat include the European venture capital firm Truffle Capital and EADS among others.
May 15, 2013