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www.european-hospital.com SURGERY 2nd artificial heart implanted in France Carmat announced, in a press release, its active recruitment of two more patients to complete its first-in- human clinical trial of the artificial heart against a primary endpoint of 30-day survival with secondary criteria for assessing the impact of the reinvigorated blood supply from the mechanical heart on internal organs. ‘We warmly thank, particu- larly today, the experienced team at CHU-Nantes,’ stated Carmat CEO Marcello Conviti. ‘Passing this step was made possible thanks to their confidence as well as that of our participants, partners and investors.’ The company was forced to issue the press release after the newspa- per Liberation reported a second implantation. Although the news leak was reported by all French media, none could report any further detail about the patient’s condition. The compa- ny imposed a news blackout regard- The Starled3 NX suits many applica- tions in the operating theatre and diagnoses in, for example, gynae- cology, dermatology and general medicine. ‘The lamp grants a homogeneous and shadow-less light thanks to its special LED optics created by ACEM Medical Company, which directs light beams at best according to the needs,’ the Italian manu- facturer reports. ‘The vis- ual area is perfectly illu- minated assuring both excellent visual comfort and working condi- tions. Its next genera- tion LEDs produce an unparalleled quality of light with a colour tem- perature (CCT) of 4.500 °K and a colour render- ing index (CRI) of 95.’ Light intensity is 130.000 lux with low energy consumption of 69W, and the life cycle of their LEDs is around an impressive 50,000 hours. The model has three reflectors producing a blended and intense cone of light, focused through automatic adjustment of the light spot diameter, the firm points out. ‘The slim, practical, compact design makes it perfect for several uses. The lamp is ergonomic, easy to move and to position and suitable for the laminar flows of the operat- ing theatre.’ The Endo function (light for endoscopy) also enables the lamp’s valuable use during Minimally invasive surgery. Other functions include touch-screen adjusted via the I-Sense control panel – cov- ering light intensity, DoF (depth of field), Size (light spot diameter adjustment), Sync (optional - to synchronise controls of the Acem Medical Company’s combined lamps when also used for exams or proce- duresC). Details: www.acem.it ing implantations after the media circus that followed the news of the first implantation and the subse- quent death of the patient 74 days later. The company’s stock price jumped on the first news and then fell dramatically with the death of the patient and statements by the inventor of the mechanical heart, renowned cardiac surgeon Alain Carpentier MD, that the device had stopped abruptly. One of the surgeons who par- ticipated in the implantation pro- cedure, Daniel Duveau MD, said that the heart did not stop brutally. ‘During two hours, each time the device stopped, the system did eve- rything it could to restart the pump. Despite a possible dysfunction, the system intelligently demonstrated its capabilities,’ he said, comparing the action to that of a doctor performing a cardiac massage. Dr Duveau was the lead surgeon for the implantation procedure at CHU-Nantes. The first patient, Claude Dany, 76, lived 74 days, which, noted lead surgeon Christian Latremouille MD, from the Hôpital Georges-Pompidou in Paris, widely exceeded the end point for the safety study. After a four-month review of the device and the causes of death of the first patient, French authorities approved the continuation of the clinical trial for safety and feasibility. In its press release, Carmat reported that two independent control com- mittees monitoring the trial had met on 4 September 2014 and issued a report approving a continuation of the trial for the final two patients. The Carmat artificial heart is the first device to completely replace a human heart and is fully con- tained within the thorax requiring no external pumps. Only two wires exit the body at the abdomen, one to supply power and the second to monitor device performance. It is also the first artificial heart capable of adapting the blood sup- ply according to a patient’s activity, varying from three to nine litres per minute, rather than having a con- stant blood supply. Carmat repeated in its press release that, in conformance with good clinical practices, there would be no reporting of results of any of the implantations until the end of this safety and feasibility trial, unless required by ‘particular cir- cumstances’. Firm imposes press embargo over new transplants Low energy, cold light, long life Another patient in the final stages of heart failure has received an artificial heart at Nantes University Hospital Centre, according to Carmat, the manufacturer of the device. John Brosky reports Carmat’s artificial heart PICTURECREDIT:Carmat A surgical led lamp illuminates countless conditions 17

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