ANDOVER, Mass., April 12, 2018 /CNW/ -- TransMedics, Inc., a medical technology company that is transforming the important therapy of solid organ transplantation for patients with end-stage lung, heart and liver failure, announced today that the results of the OCS Lung INSPIRE Trial were published in the peer-reviewed journal The Lancet Respiratory Medicine on April 9, 2018. The INSPIRE Trial was the first and largest controlled clinical organ preservation trial ever done in lung transplantation and was conducted at 21 leading international academic transplant centers. The primary objective of the INSPIRE Trial was to compare the safety and effectiveness of the OCS Lung System to the current cold storage standard of care for the preservation of standard criteria donor lungs. The trial results demonstrated assurance of the safety and effectiveness of the OCS Lung System in standard criteria double lung transplantation.
As stated in the publication, "The OCS Lung INSPIRE trial is the first prospective, multicentre, randomised, controlled study in the field of ex-vivo lung perfusion for standard bilateral lung transplantation. Both the primary effectiveness and safety endpoints were met and the trial results showed additional clinical benefits: the OCS Lung device significantly reduced Primary Graft Dysfunction Grade 3 (PGD3) within the initial 72 hours after lung transplantation. To our knowledge, this is the first reported clinical, pre-emptive therapy to reduce the incidence of severe PGD3 in lung transplantation. This reduction of PGD3 in the OCS group also translated into clinically meaningful, but not statistically significant, shorter ventilation, intensive care unit, and hospital stay times."
The publication also stated, "Furthermore, the OCS Lung device reduces ischaemic time in lung transplantation while enabling longer, safe out-of-body time of the allograft."
"This publication is an important milestone for the field of lung transplantation. For the first time, we now we have published prospective clinical evidence that there is a new modality to reduce the most severe and common clinical complication after lung transplantation – PGD3," said Dr. Gregor Warnecke, Vice Chairman of Cardiothoracic and Transplant Surgery Department in Hannover Medical School, Germany, and the Principal Investigator of the INSPIRE Trial. "I want to congratulate my co-investigators of the INSPIRE Trial and TransMedics for successfully completing this seminal trial in lung transplantation," said Dr. Warnecke.
Dr. Waleed Hassanein, TransMedics CEO, commented, "The recent publication of the INSPIRE Trial results in the prestigious Lancet Respiratory Medicine Journal is yet another keystone in the large and growing body of clinical evidence supporting the clinical benefits of the Organ Care System (OCS™) platform for ex-vivo perfusion for lung transplantation."
INSPIRE Trial Global Contributors:
Gregor Warnecke, Dirk Van Raemdonck, Michael A Smith, Gilbert Massard, Jasleen Kukreja, Federico Rea, Gabriel Loor, Fabio De Robertis, Jayan Nagendran, Kumud K Dhital, Francisco Javier Moradiellos Díez, Christoph Knosalla, Christian A Bermudez, Steven Tsui, Kenneth McCurry, I-Wen Wang, Tobias Deuse, Guy Lesèche, Pascal Thomas, Igor Tudorache, Christian Kühn, Murat Avsar, Bettina Wiegmann, Wiebke Sommer, Arne Neyrinck, Marco Schiavon, Fiorella Calebrese, Nichola Santelmo, Anne Olland, Pierre-Emanuel Falcoz, Andre R Simon, Andres Varela, Joren C Madsen, Marshall Hertz, Axel Haverich, Abbas Ardehali
About TransMedics, Inc.
TransMedics, Inc. has developed the Organ Care System (OCS™), a revolutionary first-in-class technology and multi-organ platform with the potential to both improve outcomes for transplant patients and increase the number of transplantable organs worldwide. The OCS™ is the only fully portable technology that maintains donor organs in a near-physiologic state outside of the human body and addresses the current limitations of the cold storage. The OCS™ Heart, OCS™ Lung, and OCS™ Liver systems are CE Marked and are in use at leading transplant centers in Europe, Australia and Canada. To-date there has been >950 successful human transplants using the OCS System world-wide.
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, assess organ viability prior to transplant, and potentially increase the utilization of transplant organs for the treatment of end-stage heart, lung, liver and kidney failure. For more information, please visit: www.transmedics.com
SOURCE TransMedics, Inc.
For further information: Tamer Khayal, MD, Chief Adoption Officer, Tel. 978-552-0900, [email protected], http://www.transmedics.com