Monday, December 23, 2013

Carmat heart: before marketing, the path is still long - The Point

The – Published on 23/12/2013 at 17:44

“The champagne will really slashed once” CE marked “for the heart Carmat joked Professor Latrémouille.


After the euphoria of the first implantation of artificial heart Carmat, the path is still long before the commercialization of the French aid, fruit tenacity of today octogenarian cardiologist, Professor Alain Carpentier. At last, the 75 year old patient is doing “good” and continues to recover after implantation of the first copy, high-tech blend – it is particularly capable of modulating the pace depending on the physical activity of the subject – and coating innovative taken from animal tissues.

The surgeon Christian Latrémouille, who with a team of fifteen people, operated last Wednesday for ten hours at Georges Pompidou (HEGP) European hospital this man “end of life” due to heart failure, wants to remain cautious. “Cardiac surgery is surgery very risky. Were valid step by step and yet all steps are validated. (…) We are completely in the nails,” he confided Saturday on the sidelines of a conference Press to detail made this feat in France, greeted with “Pride” by François Hollande and Jean-Marc Ayrault.

Three new locations are planned

The next steps are first patient recovery: “We will try to put sitting and standing objective is that it has a normal life. “says Professor Latrémouille. Two committees of independent experts responsible for monitoring and supervision of the implementation. They will give the green light to cross new stages, starting with a second implantation. Although Carmat already speaks three new locations “in the coming weeks,” yet no new patients were selected because “we are still in an initial phase first all” says Professor Latrémouille.

The champagne will really slashed once “CE marked” for the heart Carmat, he jokes. Several steps must be taken for it. A first phase (which started with the first implantation) will cover a total of four patients and is designed to “test the security of the prosthesis.” We then assess mainly “the 30-day survival of these patients,” all terminal phase of their illness, says Carmat.

The second phase, with twenty patients, will focus on “qualitative aspects of effectiveness” of the prosthesis designed to last “at least five years,” with the rehabilitation of bodies , quality of life, patient comfort, etc.. It is once collected and analyzed data collected over six months of survival Carmat may submit an application for the CE marking an essential step in the marketing of his heart, he hopes to pass in 2015.

A year back will be necessary

For the chief of cardiovascular surgery at the Georges Pompidou, Professor Jean-Noël Fabiani, at one year will be required to judge the heart Carmat. “I think a year back will already be very informative, and the number of patients it will take several decades to be sure of the validity” of innovation, he says. For this doctor, the prosthesis Carmat innovative because it is the first “implantable artificial heart, total, organic and final” it completely replaces the heart pump, it is covered inside “biomaterials” utilizing animal tissues and unlike its predecessors, it is not intended to be a patient wait before a heart transplant.

“What characterizes this heart is that it is totally organic in: valves and coatings,” explains Professor Fabiani. This is essential to prevent the blood – as it does on foreign surfaces, non-organic – from forming clots. So far, the implementation of “artificial hearts” must be accompanied by heavy anti-coagulation treatment, which had the biggest drawback to significantly increase the risk of bleeding. Hope with Carmat is precisely dispense with such treatments.

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