Carmat is inching closer to bringing its artificial heart to market, and the French device company is also looking to break into the U.S. through a partnership with one of its major med tech competitors.
CEO Marcello Conviti told Reuters in a wide-ranging interview that the company is on track to complete human trials involving its artificial heart by the end of 2014. The broader goal is to win Europe's O.K. to launch the device in 2015. His comments follow a number of advances: Carmat gained French regulatory approval in September to perform human implants, and will do so on four patients in three different French hospitals. Additionally, it has permission to test human implants in Belgium, Poland, Slovenia and Saudi Arabia, Reuters reported.
The focus is on patients who suffer from terminal heart failure and have very little time left. If researchers determine the device is safe, they'll further testing in lower-risk patients, according to the Reuters story.
Carmat's implant is built to replace the heart for up to five years, powered by lithium-ion batteries patients wear externally, the article explains. Bovine tissue is used to cover some of the heart's inside surfaces to help avoid clotting problems that other artificial heart devices have faced. The approach borrows from an ongoing medical device industry practice to use bovine tissue as a component of replacement aortic valves.
Assuming Carmat wins European regulatory approval, executives would then push for a similar regulatory effort in the U.S., and the CEO said he is well underway with a call for partners to make this happen. Conviti is quoted as saying in the Reuters story that his company has been "in contact" with Johnson & Johnson ($JNJ), Medtronic ($MDT), St. Jude Medical ($STJ) and Edwards Lifesciences ($EW). All are focused, in part, on heart surgery and looking to broaden their presence in that space, Conviti noted in the article.
While Carmat's advance is worth noting, the company isn't the only artificial heart developer. Abiomed ($ABMD) was initially known for its artificial heart until it shifted focus more toward devices designed to aid an ailing heart. SynCardia in Arizona is developing a next-generation total artificial heart, and startup Cleveland Heart is also well underway with efforts to develop a similar device, among others.
- read the full Reuters story