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Lung AssistDevice Developed at UK Receives Approval

LEXINGTON, Ky. (Jan.15, 2009) − Adouble lumen catheterdeveloped by University of Kentucky faculty members will soon be available for patients who suffer from severe lung failure. The FDA approved the device in October and UK will be the first medical center to offer the technology to patients later this month. The double lumen catheterallows greatly improved gas exchange during extracorporeal membrane oxygenation, known more commonly as ECMO.

Dr. Joseph B. Zwischenberger, the Johnson-Wright Professor and Chairman of UK's Department of Surgery, and Dr. Dongfang Wang, director of UK's Artificial Organ Laboratory, developed the high performance double lumen catheter in collaboration with Avalon Laboratories, LLC. This new device is simpler, less invasive, and expands the potential applications for the use ofECMO.

"The doublelumen catheter could potentially enhance and save the lives of many people who suffer from severe lung diseases," Zwischenberger said. "It provides more efficient and less traumatic total gas exchange for lung function support in adults and children. The design consists of a single catheter that drains blood from the upper and lower body and reinfuses it right into the heart, providing the ability for patients to survive despite temporary lung failure.With currently available DLCs, only for use insmallchildren, significant recirculation, insufficient venous drainage, and issues with kinking and collapsingmay lead to insufficient gas exchange. Until now, no DLC existed for adults or large pediatric patients. "

Zwischenberger expects the device could be used to give patients time to recover from lung injury, disease, or as a stop gap measure to await lung transplantation. Traditional mechanical ventilators have served as artificial lung support for the past 30 years, but there are complications associated with patients being connected to mechanical ventilation for long periods of time. The device, known as the Avalon Elite™ Bi-Caval DLC,is less invasive, allows for patient mobility,and lessens opportunity of infection. The double lumen catheter is inserted directly through the skin into the patient's rightinternal jugular vein (neck vein) with a drainage lumen open to both the superior vena cava and inferior vena cava to maximize venous drainage. A separate collapsible infusion lumen, open to the right atrium,facilitates the return of blood through a single insertion site. This design achieves minimal recirculation, allowing for total gas exchange and providing total respiratory support in the ICU setting when coupled with an external pump and oxygenator.

Lung failure is the 4th leading cause of death in the U.S. and affects all ages, from babies and children to adults. Zwischenber says that this system could benefit many patients in Kentucky, which has some of the nation's highest rates of lung cancer, emphysema, bronchitis, chronic obstructive pulmonary disease (COPD) and other lung ailments related to the state's typically high smoking rates. The only current treatment for chronic irreversible pulmonary failure is lung transplantation. Although single and double lung transplants have successfully been done since the early 1990s, the demand for donor lungs has steadily outgrown the supply. Unlike dialysis, which functions as a bridge to renal transplant, or a ventricular assist device (VAD), which serves as a bridge to cardiac transplantation, no suitable bridge to lung transplantation exists. Current methods used are costly, labor-intensive, time limited, and can include complications to the patient.

Zwischenberger, a Kentucky native, brought the double lumen catheter project with him when he was recruited in 2007 as chairman of the Department of Surgery from the University of Texas Medical Branch. He has been working on plans for an artificial lung for 25 years and began partnering with Wang eight years ago. Both believe that the DLC is a step towards achieving success on this quest.

"UK is now well positioned to be a leader in this field," Zwischenberger said.

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