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ANDOVER, Massachusetts, April 15 /PRNewswire/ -- The clinical results of the international PROCEED II heart trial with the OCS™ Heart platform has been published today by the Lancet Journal. The manuscript was published online coinciding with the start of The International Society for Heart and Lung Transplantation (ISHLT) 35th Annual Meeting and Scientific Sessions in Nice, France.
The OCS Heart PROCEED II FDA pivotal trial met its success criteria for both the primary effectiveness and safety endpoints by demonstrating that the OCS is as safe and effective as the current standard of care (SOC) in preserving standard donor hearts for transplantation. These results were achieved despite the OCS arm having nearly double the total cross clamp time as compared to SOC. In addition, the data from PROCEED II Trial demonstrated that circulating lactate level of the OCS Heart perfusion could be a useful parameter to evaluate donor hearts status ex-vivo.
"The human heart was never meant to be on ice," said Dr. Abbas Ardehali, the surgical director of UCLA's heart and lung transplantation program and the trial's principal investigator. "The completion of this trial and the publication of the results in the Lancet is an important foundational step in bringing beating heart transplants into our routine clinical practice in the U.S."
"The successful completion of the OCS Heart PROCEED II pivotal trial is a critical milestone to support our FDA PMA application to bring the OCS Heart life saving technology to the U.S. Market. This large international trial is an important cornerstone in the growing global clinical body of evidence supporting the concept of ex-vivo heart perfusion (EVHP) as a viable clinical option for donor heart preservation for transplantation to overcome the challenges of cold ischemic storage," said Dr. Waleed Hassanein, President and CEO of TransMedics, Inc.
TransMedics Inc. is the world's leader in portable ex-vivo machine 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.
For more information, please visit www.TransMedics.com.
Neal Beswick, TransMedics, Inc.
Tel.: +1 (978) 289-2615