The OCS™ Lung Initial European Clinical Experience Featured in The Lancet
ANDOVER, Mass., Oct. 10, 2012 -- /PRNewswire/ -- The Lancet has published the initial series of successful lung transplants demonstrating the feasibility and safety of using the Organ Care System™ (OCS™) Lung technology, at Hannover Medical School and Puerta de Hierro Hospital Madrid.
A study published in the October 10th edition of The Lancet reports on the first in-man clinical experience with the OCS Lung technology. These cases were conducted in two leading lung transplant centers in Germany and Spain. Representing a full spectrum of donor and recipient risk factors/indications for lung transplantation, these cases evaluate the feasibility and safety of the OCS technology. All lungs were successfully preserved on the OCS system and transplanted with excellent results. This study was the foundation to initiate the ongoing international prospective randomized INSPIRE Trial to evaluate the effectiveness of the OCS Lung device.
"Our early clinical data supports the use of the OCS Lung. We show good outcomes of lung transplantation following preservation on OCS Lung in a high-risk recipient population," said Dr. Gregor Warnecke at the Hannover Medical School in Germany. "The full potential of this technology will be exemplified in the data resulting from the ongoing INSPIRE Trial and we are enthusiastic to move this important trial forward.
"We are excited by The Lancet publication and we look forward to continuing our global collaboration with leading lung transplant centers to complete and report the results from the INSPIRE Trial," said Dr. Waleed Hassanein, President and CEO of TransMedics, Inc.
INSPIRE is an international, multi-center, large clinical trial that is randomizing subjects. It will evaluate the success of lung preservation using OCS technology as compared to traditional cold-storage preservation. The INSPIRE Trial is approved under the US Food & Drug Administration for an investigational device exemption (IDE), and it is currently enrolling patients in leading lung transplant centers in Europe, US, Australia, and Canada. For more information about the INSPIRE Trial, visit www.inspireclinicaltrial.com.
About OCS Since the advent of transplantation, the cornerstone of organ preservation has been cold ischemic storage (organs on ice). Although this method is intended to help reduce the extent of organ damage during transport, significant damage still occurs. The longer an organ is stored this way, the more damage occurs. Moreover, the cold-storage technique does not enable any optimization or monitoring capabilities during transportation from donor to recipient. It is estimated that only 15-20% of donor lungs are utilized for transplantation globally based on the limitations of cold storage. TransMedics has developed the world's only portable medical device capable of overcoming the above limitations of cold storage for organ transplantation. OCS technology was designed to provide a comprehensive solution to all three key limitations of the cold storage technique. OCS Lung:
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