UK's National Institute for Health and Care Excellence (NICE) grants positive recommendation for procedure enabled by TransMedics OCS™ Heart ex-vivo perfusion and assessment technology
ANDOVER, Massachusetts, March 22, 2016 /PRNewswire/ -- TransMedics, Inc., the global leader in portable ex-vivo perfusion of donor organs for transplantation, announces NICE's recommendation for normothermic extracorporeal preservations of hearts for transplantation following donation after brainstem death – the procedure enabled by the OCS™ Heart technology. NICE – The UK's National Institute for Health and Care Excellence – has issued their most positive recommendation available for an interventional procedure, indicating that there is enough evidence to show that the procedure works and is safe for doctors to consider it as an option for their patients following their hospital's standard policies.
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Since the advent of organ transplantation, the cornerstone of organ preservation has been cold ischaemic storage (placing organs on ice). As described in the guidance document issued by NICE, "Prolonged cold storage times may result in ischaemic and reperfusion injuries that can impair heart function after transplantation." "Normothermic extracorporeal preservation aims to keep the donor's heart beating outside the body, using a perfusion machine that delivers warm oxygenated blood supplemented with catecholamine, nutrients and electrolytes."
The TransMedics Organ Care System (OCS™) Heart is the first and only medical device capable of maintaining donor hearts beating and perfused outside of the human body from the time the organ is removed from the donor until it is ready to be transplanted into a suitable recipient. It was developed to overcome the limitations of cold storage by minimizing ischemia, optimizing the organ's condition, and enabling continuous monitoring and assessment of the heart outside the body, with the goal of making more hearts available for transplantation and improving patient outcomes.
The OCS™ Heart system is being utilized in leading transplant centers in the UK and throughout Europe. Mr Andre Simon, director of organ transplantation and consultant cardiac surgeon at Royal Brompton & Harefield NHS Foundation Trust, is one of the early adopters of the technology in the UK and has extensive experience using the OCS platform for both heart and lung transplantation. "Organs were never meant to be put on ice," says Mr. Simon. "Previously we had no alternative, but now with the OCS™ technology we can significantly extend the length of time an organ can be kept before transplant. This technology has the potential to revolutionize organ transplantation."
The guidance from NICE – the independent body responsible for driving improvement and excellence in England's health and social care system – was issued after an extensive review of the medical literature and solicitation of input from specialist advisers. "Receiving this recommendation from NICE is an important recognition of TransMedics' commitment to developing the largest body of prospective clinical evidence in organ preservation," said Dr. Waleed Hassanein, President and CEO of TransMedics, Inc.
About TransMedics, Inc.
TransMedics Inc. is the world's leader in portable ex-vivo warm perfusion and assessment of donor organs for transplantation. Headquartered in Andover, Massachusetts, the company was founded to address the unmet need for more and better organs for transplantation, and has developed technologies to improve organ quality, validate organ viability, and increase the utilization of transplant organs for the treatment of end-stage heart, lung, liver and kidney failure. The OCS™ Heart and OCS™ Lung systems are CE Marked and used by leading transplant centers in Europe, Australia and Canada, and are currently in clinical trials in the United States. For more information, please visit: www.TransMedics.com.
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