New preservation system for donor lungs for transplant

This portable version of the Toronto Ex-vivo Lung Perfusion System offers great hope for the safe transportation of donor lungs to the recipient without incurring the damage the present cold storage preservation system causes. Only 15-20% of current donor lungs turn out to be suitable for transplant due to this damage that the Ex-vivo Lung Perfusion System can repair and recondition.

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:

Minimizes cold ischemia injury by perfusing the organs with a proprietary warm perfusate

Optimizes the condition of organs by replenishing oxygen, nutrients and hormones that are depleted

Provides continuous monitoring and assessment capabilities for the organs until the point of transplantation

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 transplants. For more information, please visit www.TransMedics.com. SOURCE TransMedics, Inc. Read more here:

“You Have the Power to Donate Life – Sign-up today! Tell Your Loved Ones of Your Decision”

Canada Ontario, Canada - British Columbia, other Canadian provinces

United States, organdonor.gov

United Kingdom, register at NHS Organ Donor Register

Australia, register at Australian Organ Donor Register

Your generosity can save or enhance the lives of up to fifty people with heart, kidneys, liver, lungs, pancreas and small intestine transplants (see allotransplantation). One tissue donor can help by donating skin, corneas, bone, tendon, ligaments and heart valves

Has your life been saved by an organ transplant? "Pay it forward" and help spread the word about the need for organ donation - In the U.S. another person is added to the national transplant waiting list every 11 minutes and 18 people die each day waiting for an organ or tissue transplant. Organs can save lives, corneas renew vision, and tissue may help to restore someone's ability to walk, run or move freely without pain. Life Begins with You

ExVivo Lung Perfusion system transplant performed at University of Maryland

First U.S. Patient Receives Specially Processed Donor Lungs

Newswise — Baltimore, MD – September 7, 2011 – Surgeons at the University of Maryland Medical Center have transplanted the first lungs treated in the United States with an experimental repair process before transplantation. The procedure is part of a five-center national clinical research trial to evaluate the efficacy of repairing, before transplant, lungs that might otherwise have been passed over as unsuitable for organ donation. The results of this study, if successful, could significantly expand the number of transplantable lungs available to patients awaiting transplants.

Currently, only 15-20 percent of donor lungs are transplantable; most do not meet transplant criteria. The research focuses on an external perfusion technique using a fluid called STEEN SolutionTM .

More than 1,700 people are on the lung transplant waiting list in the U.S., including nearly 30 in Maryland, according to the United Network for Organ Sharing.

“We are excited about the prospect of what this ex vivo, out-of-the-body perfusion technique could mean for our many transplant candidates who often spend years waiting for lungs to become available,” says the principal investigator, Bartley P. Griffith, M.D., professor of surgery at the University of Maryland School of Medicine and chief of cardiothoracic surgery at the University of Maryland Medical Center. “This research is part of our ongoing goal to develop innovative procedures and rapidly improve our patients’ quality of life.”

Lungs in this clinical trial are recovered using current donor lung retrieval techniques. Once brought to the study transplant center, the lungs are re-assessed by the transplant team. The lungs are then physiologically assessed during ex vivo perfusion with STEEN SolutionTM over a period of three to four hours. During this time, the transplant team evaluates abnormalities inside the lungs, oxygenation levels and overall health of the lungs. At the end of the process, the transplant team determines if the lungs meet the high standards necessary for transplantation.

“Our goal is to constantly advance science and medicine in order to better serve our patients,” says E. Albert Reece, M.D., Ph.D., M.B.A., vice president of medical affairs at the University of Maryland and dean of the University of Maryland School of Medicine. “Clinical trials, such as this ex vivo lung perfusion, are an important tool to help us apply discovery from the laboratory to patient care at the bedside.”

“Studies from other sites outside the U.S. have demonstrated that the results after transplantation using this ex vivo technique were at least as good as lungs that had not required perfusion,” says Griffith. “These findings, plus the expertise from within our own center, give me great confidence in the future use of this ex vivo perfusion technique as an option to potentially increase our pool of transplantable lungs and reduce long wait times for our transplant candidates.”

STEEN SolutionTM is a product of Xvivo Perfusion, part of the Vitrolife Group, Goteborg, Sweden.

About the University of Maryland Medical Center

The University of Maryland Medical Center is a 779-bed teaching hospital in Baltimore, Md., that provides a full range of health services to people throughout Maryland and the Mid-Atlantic region. It is a national and regional referral center for trauma, cancer care, cardiac care, neurocare, women's and children's health and organ transplants. All of the hospital’s physicians are faculty physicians of the University of Maryland School of Medicine, the oldest public medical school in the United States, founded in 1807.

The Medical Center, established in 1823, is one of the nation's first teaching hospitals. The University of Maryland Medical Center is the flagship hospital of the University of Maryland Medical System, a private, not-for-profit network of 12 academic, community and specialty hospitals throughout Maryland.
Source University of Maryland Medical Center

Merv's note:
The Ex-vivo Lung Perfusion System that is used to recondition and repair lungs that would normally be unusable for transplant was introduced at Toronto General Hospital, University Health Network about 3 years ago and has been very successful. View the video of Dr. Shaf Keshajee, Director of the Toronto Lung Transplant Program, presenting the system at TEDMED 2010

“You Have the Power to Donate Life – Sign-up today! to become an organ and tissue donor
Tell Your Loved Ones of Your Decision”

Australia, register at Australian Organ Donor Register

New Zealand, register at Organ Donation New Zealand

Canada - Ontario beadonor.ca
other Canadian provinces

South Africa, http://www.odf.org.za/

United States, organdonor.gov

United Kingdom, register at NHS Organ Donor Register

Your generosity can save or enhance the lives of up to fifty people with heart, kidneys, liver, lungs, pancreas and small intestine transplants (see allotransplantation). One tissue donor can help by donating skin, corneas, bone, tendon, ligaments and heart valves

Has your life been saved by an organ transplant? "Pay it forward" and help spread the word about the need for organ donation - In the U.S. another person is added to the national transplant waiting list every 11 minutes and 18 people die each day waiting for an organ or tissue transplant. Organs can save lives, corneas renew vision, and tissue may help to restore someone's ability to walk, run or move freely without pain. Life Begins with You