Coming Soon: World's First Bioprosthetic Artificial Heart
By Sara Jerome,
@sarmje
The world's first bioprosthetic total artificial heart is getting closer to hitting the market.
The French company Carmat "hopes to finish human trials of its artificial heart by the end of next year and to obtain regulatory approval for an EU launch by early 2015," Marcello Conviti, the firm's chief executive, told Reuters.
Heart assistance devices are not new, but Carmat’s technology is more technologically sophisticated and would offer greater longevity than previous designs.
Traditionally, artificial hearts have been used "as a temporary solution for patients awaiting a transplant," Reuters said. But the new product "is designed to replace the heart for up to five years, mimicking nature's work using biological materials and sensors."
Engineering & Technology Magazine described the new device: "Developed by a team of Airbus engineers, the 900g Carmat device mimics heart muscle contractions and contains sensors that adapt the blood flow to patient's moves."
Internal surfaces of the heart will contact human blood are partially composed of bovine tissue, making them less likely than synthetic materials (like plastic) to cause blood clots.
“The way they’ve incorporated biological surfaces for any place that contacts blood is a really nice advantage,” Joseph Rogers of Duke University told the New York Times. “If they have this design right, this could be a game changer.”
Carmat’s heart will be powered by external, wearable lithium-ion batteries and will weigh almost three times as much as an average human heart — meaning initial patients will likely be men. However, Conviti claims the company could “easily” manufacture a smaller version that would fit in women and men of slight build.
The heart is expected to cost between £117,000 and £150,000 ($189,000 and $242,000), E&T said.
Carmat won approval for human clinical trials in France, Belgium, Poland, Slovenia, and Saudi Arabia earlier this year. It is planning to double down on efforts to get U.S. regulatory approval after passing muster in Europe, according to Reuters.
The company is also scouting U.S. companies to join forces with it. The firm wants a partner "to enter the world's largest healthcare market, and is in contact with Johnson & Johnson, Medtronic, St. Jude Medical, and Edwards Lifesciences," according to Reuters.
"All the major companies active in heart surgery... are interested in widening their patient base. We are in contact with these companies," Conviti told Reuters.
Click here for more information on the Carmat heart.
Image courtesy Carmat