TransMedics® Announces Interim Results From The International INSPIRE Pivotal Trial Using The OCS™ Lung System
ANDOVER, Mass., April 25, 2013 /PRNewswire/ -- Interim results from the International INSPIRE Trial presented today at the International Society for Heart and Lung Transplantation (ISHLT) 33rd Annual Meeting in Montreal, are indicating significant improvement in post-lung transplant clinical outcomes using the TransMedics Organ Care System (OCS) Lung portable perfusion and ventilation system.
Data from the ongoing pivotal international randomized trial of the TransMedics OCS Lung preservation and transplantation (INSPIRE) was presented this morning at the ISHLT annual meeting in Montreal by Dr. Gregor Warnecke, Director of Lung Transplantation at Hannover Medical School, Germany and the International Principal Investigator of the INSPIRE Trial. The INSPIRE Trial is the largest prospective trial to evaluate the impact of portable ex-vivo perfusion and ventilation of donor lungs on post-lung transplant outcomes as compared to current cold storage technique.
Dr. Warnecke's presentation revealed that the donor lungs preserved using the OCS Lung technology had significantly lower incident of severe primary graft dysfunction grade 3 (PGD 3) after lung transplantation as compared to lungs that were preserved using cold storage. In addition, other important clinical parameters like in-hospital mortality, six months survival, rate of lung related complications, time on mechanical ventilation and ICU time were better in the OCS group as compared to cold storage.
"PGD 3 is the most severe form of post transplant lung ischemia and reperfusion injury and is correlated with early and late mortality after lung transplantation. The significant reduction in PGD 3 in the OCS treated group is very encouraging and we look forward to the final trial outcomes," said Dr. Warnecke. "If these positive trends continue, we believe the results will represent a huge step forward in the field of lung transplantation."
"The late breaking preliminary results of the INSPIRE trial hold great promise of the successful development of technology to reduce the incidence of PGD 3 of the pulmonary allograft which should translate into superior short and long term outcomes, " said Allan Glanville, M.D., Director of Thoracic Medicine at St. Vincent's Hospital, Sydney, Australia and Program Chair of this year's ISHLT annual meeting. "PGD is the most significant cause of early mortality and is strongly related to late outcomes of chronic lung allograft dysfunction. Importantly the results show the incidence of PGD was lower at all time points examined in the active group. While six month survival results do appear lower than expected in the control group at this stage, final results with longer term follow up are awaited with great interest."
"We are very encouraged by the interim results of INSPIRE and we are looking forward to completing this important trial soon. If the data continues on this trajectory, this global initiative could be the foundation to set the new standard of care for lung transplantation worldwide," said Dr. Waleed Hassanein, President and CEO of TransMedics Inc.
What is the TransMedics Organ Care System?
Since the advent of organ transplantation, the cornerstone of organ preservation has been cold ischemic storage (essentially placing organs on ice). Although this method is intended to reduce the extent of organ damage during transport, significant deterioration of the donated organ still occurs. The longer the organ is kept on ice, the greater the damage. Moreover, the cold storage technique does not enable any optimization or monitoring while the organ is being transported from donor to recipient. Given the limitations of cold storage, it is estimated that globally 80% to 85% of donor lungs cannot ultimately be used for transplantation.
TransMedics has developed the world's only portable medical device capable of overcoming the limitations of cold storage for organ transplantation. The OCS technology was designed to provide a comprehensive solution to all three key limitations of the cold storage technique. The OCS:
- Minimizes cold ischemia injury by perfusing the organ with a blood based perfusate
- Optimizes the condition of the organ by replenishing oxygen, nutrients, and hormones that would otherwise become depleted;
- Provides continuous monitoring and assessment of the organ until the point of transplantation
These unique capabilities of the OCS technology have the potential to:
- Improve patient survival
- Reduce post-transplant complications
- Increase utilization of current donor organs
- Improve cost-effectiveness of the transplant procedure
INSPIRE is a large international, multi-center, randomized clinical trial designed to evaluate the success of lung preservation using OCS technology compared to traditional cold-storage preservation. INSPIRE was approved by the U.S. Food & Drug Administration for an investigational device exemption (IDE). It is currently enrolling patients in leading lung transplant centers in Europe, the United States, Australia, and Canada. For more information about INSPIRE, visit www.inspireclinicaltrial.com.
About TransMedics, Inc.
TransMedics is a privately held medical technology company dedicated to extending the life saving benefits of organ transplantation to patients suffering from end-stage organ failure. Headquartered in Andover, Massachusetts, the company was founded in 1998 to address the unmet need for more and better organs for transplantation. For more information, please visit www.TransMedics.com.
SOURCE TransMedics, Inc.