The device is designed to replace a natural coronary artery lasting 5 years for patients with cardiac failure in a terminal stage.
In December 2020, the European Medicines Agency will make the most of this opportunity for Carmat, a manufacturer of French braces, to start selling its devices, now in the form of “bridge to transplant” and no permanent implant, from second trimester of this year, reclaimed Reuters.
“We have our ambition to treat all patients who need a coronation”, said Carmat’s CEO Stephane Piat, adding that we know that the number of potential clients is huge. According to estimates, there are already 2,000 people in France, Germany, Italy, Spain and the United Kingdom in the hope of a transplant.
However, the Carmat device, which is commercialized at both the Aeson brand, will be available primarily in Germany, possibly following France and other countries. At the same time, he stated that one of the principal principles for his company consisted in claiming the rebate on the part of the social security systems by the artificial race, cuyo price per unit will be 150,000 euros (182,000 dollars).
With the intention of expanding into the transplant market, Carmat announced that this semester it will start studying at EE.UU. with the hope of obtaining the approval of the Food and Drug Administration (FDA, by its seal in English) by the year 2024.
Functioning
Carmat’s mechanism is designed to replace the natural corona lasting approximately 5 years, imitating its work with biological materials and sensors. His goal is to extend the life of miles of patients that mueren each year hopes a donor. It has a weight of 900 grams, approximately three times more than a normal human race, and works with lithium ion batteries.
Generate an autonomous blood circulation at the physiological level. The prosthesis is developed from the components, both organic, as well as materials used in the aerospace industry. It is therefore in addition to physicians, participating in the engineering work of the Matra Defense company, of the Airbus-groep aeronautical consortium.
History
The approval of the European regulatory authorities concludes a lengthy elaboration process, row duro 27 years ago and also vio reves.
In die 2008 Carmat presented a revolutionary prosthesis as a solution to patients with cardiac insufficiency and which does not have access to a natural donor. The company will wait several years to obtain the permission of the French authorities to carry out 4 sustainability studies of the procedure.
Without embarrassment, the company is temporarily obliged to suspend clinical trials of its artificial coronation, despite the fact that the first patient fails both months and mid after the surgical intervention. Cabe signals that antes of the pusieran the device, the male suffers from insufficient cardiac terminal. It is estimated that the quedaban only a few weeks, including days, of life.
Carmat reopened its activities in July 2014 and in September of this year, following its second operation, it has been closed. For 2016 Carmat will operate 4 patients, and the program will be extended to include groups of 10 people each. In 2018, the company will ensure that all participants in one of these groups show “positive results” in clinical trials.
In the 2017 Carmat sent to the European Commission the application to receive the authorization for the commercial distribution of its product, and at the same time continuously expanding the studies.