An artificial heart that can give patients up to five years of extra life has been successfully implanted for the first time.
The heart, powered by watch-style batteries that can be worn externally, was put into a patient at Paris’s Georges Pompidou Hospital.
It uses a range of “biomaterials”, including bovine tissue, to reduce the likelihood of the body rejecting it.
Unlike previous artificial hearts, created mainly for temporary use, the design by the French Carmat biomedical firm is intended to replace a real heart for as many as five years.
French medics said the unnamed male patient who received the device was awake and responding well after an operation on Wednesday. Marcello Conviti, the chief executive of Carmat, said: “We are delighted with this first implant, although it is premature to draw conclusions given that a single implant has been performed and that we are in the early post-operative phase.”
The artificial heart, developed with the help of engineers from the Dutch-based European Aeronautic Defence and Space Company (EADS), weighs 2lbs — almost three times as much as an average healthy human heart. It mimics heart muscle contractions and contains sensors that adapt the blood flow to the patient’s moves.
Inside the heart, surfaces that come into contact with human blood are made partly from bovine tissue instead of synthetic materials such as plastic, which can cause blood clots.
The new device could help thousands of people who die each year while waiting for a donor, including many in Britain. Nearly 100,000 people in Europe and the United States are in need of a heart transplant, according to Carmat. The company claims its device should enable hospital patients to return home and possibly even resume work.
Alain Carpentier, the surgeon who performed the implant, said: “It’s about giving patients a normal social life with the least dependence on medication as possible.
“We’ve already seen devices of this type but they had a relatively low autonomy. This heart will allow for more movement and less clotting. The study that is starting is being very closely watched in the medical field.” Heart failure affects more men than women, and the size of the artificial heart means it can fit in 86 per cent of men’s bodies but only about 20 per cent of women. However, Carmat says it can manufacture a smaller version to fit the more petite bodies of women as well as patients in India and China.
The artificial heart will raise France’s reputation as a country at the forefront of medical innovation.
In 2005, surgeons in France performed the first face transplant on Isabelle Dinoire, whose features were badly mutilated by a dog.
Marisol Touraine, France’s health minister, was quick to praise the operation as a sign of the country’s edge in the field of health care.
“This news brings great pride to France,” he said. “It shows we are pioneers in health care, that we can invent, that we can carry an innovation that will also bring great hope to plenty of people.”
Carmat won permission from the French authorities to test the human implants on four patients in three hospitals last September.
All were suffering from terminal heart failure.
While the intention is for each heart to keep a patient alive for five years, the success of the device in the trials will be judged on whether they survive with the implant for at least a month. Carmat hopes to finish human trials of the heart by the end of next year and to obtain approval to market the devices in the EU by early 2017.
It is expected to cost €140,000 (£120,000) to €180,000 (£150,000) if and when it goes on sale in Europe. The company’s shares have risen fivefold since floating on the Paris stock market in 2010. Among Carmat’s competitors in the race to perfect artificial heart implants are the privately-owned company, SynCardia Systems, and Abiomed, both of the United States.
The longest a patient has lived with a SynCardia heart is just under four years.
A spokesman for SynCardia said: “We’re very happy for them and we wish them the best in their pursuit.”
据英国《每日电讯报》12月21日报道,法国巴黎蓬皮杜医院医生成功地为病人体内植入一颗能为他延长寿命5年的人工心脏。
这颗人工心脏采用手表式电池,重达2磅(0.9千克),几乎为健康心脏重量的3倍。其与人血接触的表面有些部分为牛的组织制造而成,而非会形成血栓的塑胶等合成材料。心脏内安有电子传感器,能够根据患者活动情况对血压及心率等进行调节。
与以往主要用于临时使用的人工心脏不同,法国加尔玛生物医学公司设计的这颗人工心脏可以替代真正的心脏长达5年。
这名男性患者手术后已经苏醒,反应良好,已经和家人说话。手术医生阿兰·卡尔庞捷说,“它将让病人恢复正常社会生活,尽可能少地依赖药物。”
加尔玛公司首席执行官马尔切洛表示:“我们对这次首次移植感到高兴,但仅仅因一次移植就得出结论为之尚早。”该公司称,这种人工心脏可以让病人出院回家,甚至重新回到工作岗位。
男性比女性更容易受到心衰的影响。这么大的人工心脏适合86%的男性身体,但只适用于20%的女性。加尔玛公司表示可以制造更小型的人工心脏,适应女性以及中国和印度患者的体型。
加尔玛公司希望在明年底完成临床试验并于2017年获准在欧洲上市,预计售价约为12万到15万英镑。据悉,欧洲和美国有近10万人需要心脏移植。
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