Sentara begins international trial -- open at only 24 US locations

September 25, 2008

Norfolk, VA - September 23, 2008- Researchers at Sentara Cardiovascular Research Institute begin a new international study to explore the safety and effectiveness of stents to open airways of patients with advanced emphysema or Chronic Obstructive Pulmonary Disease (COPD).

The EASE (Exhale Airway Stents for Emphysema) Trial focuses on airway bypass, an investigational technique without surgery to create new pathways to release trapped air from within diseased lung tissue, thereby helping patients with advanced widespread emphysema breathe easier.

Similar to the stents used to prop open clogged arteries in heart patients, these drug-eluting stents are now holding open new passageways in the lungs.

Pulmonologists and cardiothoracic surgeons at Sentara Thoracic Surgery Center in Norfolk, Virginia are collaborating to perform this investigational procedure of the first wave of Virginia participants. During the procedure, a tube is guided through the mouth of trial participants to access the lung and implant up to six stents smaller than a pencil eraser. The goal is to relieve breathlessness and over inflated lungs - hallmarks of this incurable, progressive disease.

Traditional treatment options for patients with severe emphysema are limited to lung reduction surgery, lung transplant, and inhalers, which have diminishing impact as the disease progresses. Airway bypass, done without open surgery, is considered minimally invasive and hoped to be an option for broader numbers of patients.

"Emphysema is really life limiting. Some of my patients who golfed a year ago now get winded taking a shower," says cardiothoracic surgeon Joseph Newton, Sentara Cardiovascular Research Institute's principal investigator for this trial. "Through research like this, I'm hopeful we are going to find a way to help these patients do things most of us take for granted," he continues.

That's just what trial candidate John Woodard is hoping for. The 61-year-old Suffolk resident is being evaluated Tuesday, September 22 at Sentara to begin the enrollment process.

"I don't look sick," says Woodard. "You wouldn't know any better until you saw me exercise," continues Woodard who ran 35 miles each week up until about 10 years ago. Woodard retired a year ago because of his condition. "I still play golf, but I have to bring my oxygen with me," he says.

"Research like this gives new hope of a longer-term solution for more people. Transplant is not a practical option for a lot of people with severe emphysema," says Dr. Carolyn Fruci, pulmonologist and critical care specialist involved in the study. "What's exciting is the possibility of patients regaining some of the everyday freedoms lost to this disease," Fruci continues.

Transplant, one of the only treatments today for patients with severe emphysema, is not plausible for every patient. Participation in this trial does not prevent patients from being considered for lung transplantation at a later time.

For Woodard, who has been coping with COPD for the last 10 years, participating in this research offers hope. "I'm up for most anything. Naturally if there's any benefit--to me or anybody else--that would be wonderful," say Woodard, who is being evaluated for participation in the trial.
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About the Study

The EASE Trial, sponsored by stent maker Broncus Technologies, is a double blind, sham-controlled, randomized study to evaluate the safety and effectiveness of a new procedure called airway bypass, which was first shown to be feasible in 2003.

Sentara Cardiovascular Research Institute, in conjunction with Sentara Thoracic Surgery Center, is one of only 24 U.S. locations involved in this trial to date and is currently enrolling patients. Minimum requirements for participation in the EASE Trial stipulate that participants are 35 years or older, have been diagnosed with advanced, widespread emphysema, and have stopped smoking at least two months prior to entering the trial. Involvement in the study will last from approximately 15 months up to 5 years (depending on if the patient is randomized to the control or the treatment group) and include 8 to 16 physician appointments. All study-related medical procedures will be carried out at no charge to the patient and patients will be closely monitored throughout the trial. These are only the basic conditions for participation and patients are asked about other conditions before enrolling. For more information please call 866-431-3273 or visit www.EASEtrialUS.com

Results from the open-label Exhale Drug-Eluting Stent feasibility study were published in the October issue of the Journal of Thoracic and Cardiovascular Surgery. Positive results included a statistically significant reduction in the amount of air trapped in the lungs and an improvement in breathing for patients at six months after the airway bypass procedure.

For more information, visit www.sentara.com.

Broncus Technologies

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