Wednesday, May 15, 2013

Carmat has won approval to proceed with the first implantations of artificial hearts

PARIS | Tue May 14, 2013 10:00am EDT
(Reuters) - France's Carmat has won approval to proceed with the first human implantations of its artificial heart in four countries, the company said on Tuesday, sending its shares up 25 percent.
The approval were given by the four international cardiac surgery centers in Belgium, Poland, Saudi Arabia and Slovenia, where the tests will be carried out, but not in France, where Carmat's artificial heart is still to gain approval from the drug safety agency, ANSM.
Shares of Carmat rose 24.56 percent at 12.12 GMT to 129.5 euros, valuing the company at 535 million euros ($694.56 million).
Among Carmat's competitors are privately-held SynCardia Systems andAbiomed Inc., both of the United States.
The approval is "good news" that allows the French medical devices maker "to make progress on the subject of human implantation despite the growing demands of the ASNM," Portzamparc analysts wrote in a note.
The French regulator has asked Carmat to test the device on animals before it can allow implantation in humans.
"The patient selection process and the training of the clinical teams are ongoing in these four countries (...) Implantations could start shortly following the completion of the training," Carmat said in a press release.
Developed by a team of engineers from Airbus parent company EADS, the Carmat devices - expected to cost 150,000 euros ($193,600) each - mimic heart muscle contractions with two micro pumps, one for each ventricle or heart chamber.
"Carmat expects to receive additional approvals in a near future, potentially in France and in other countries," Chief Executive Marcello Conviti said in the press statement.
Last October, Carmat had said it expected to seek approval for its artificial heart from French authorities by the end of the year, enabling it to carry out its first implant in early 2013.
($1 = 0.7703 euros)
(Reporting by Alice Cannet; editing by James Jukwey)

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