Carmat notches a win as artificial heart patient returns home

Schematic of Carmat's artificial heart--Courtesy of Carmat

France's Carmat reached another milestone in its quest to bring its artificial heart to market, as a patient who received the device in August has recovered enough to return home.

The 68-year-old patient wants his identity to remain confidential, but was discharged from Nantes University Hospital in France on Monday with a silent electric portable power and alert system to monitor his implant, the company said in a statement. The man, who had terminal congestive heart failure, "is living a completely normal life now" and is "pedaling like crazy" on a stationary bicycle, Dr. Alain Carpentier, the French surgeon who invented the device, told French daily newspaper Le Parisien.

Carmat's shares were up by more than 17% on Monday in morning trading in Paris. The company's stock had lost 39% of its value in the 12 months through the market close on Friday, The New York Times reports.

The news bodes well for Carmat as it looks to make headway with its artificial heart implant. The device is made to replace the heart for up to 5 years and is powered by lithium-ion batteries that patients wear externally. It is made with synthetic materials and bovine tissues, and replaces the two lower chambers, or ventricles, of the heart.

In December 2013, the company implanted the device in its first human subject, a 76-year-old man. He lived for 74 days, well past the benchmark trial time of 30 days. Carmat hopes to sell the device to patients who do not qualify for transplants or who do not have additional treatment options. If all goes according to plan, the device would eventually sell for €140,000 to €180,000 ($162,000 to $208,000) and could expand the market for artificial hearts from 4,000 patients to 125,000 patients annually, the company said.

But Carmat still faces some hurdles on its path toward full commercialization for the product. The company is focusing on finishing current medical trials for its artificial heart, which includes enrolling two more patients. The study will be published after the trials are concluded, after which point Carmat "will massively communicate" the next step, company spokeswoman Caroline Carmagnol told the NYT.

And Carmat is not the only company making headway with an artificial heart device; Tucson, AZ-based SynCardia Systems is also forging ahead with development of its Total Artificial Heart, plugging for the first FDA approval of an artificial heart implant for permanent use. The agency has already approved the device as a temporary bridge to transplant for patients suffering from end-stage biventricular heart failure and recently gave a green light to a pivotal trial for the product. The new study will include 19 patients who need a heart transplant but are not eligible for a donor heart, SynCardia said in a statement.

- read Carmat's release (PDF)
- here's the Le Parisien article (in French)
- get more from The New York Times (sub. req.)

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