Mountain View, CA - July 17, 2013 – El Camino Hospital in partnership with Fogarty Clinical Research, part of the Fogarty Innovation Institute, announced today that it will participate in the national FDA-approved RENEW clinical trial of the RePneu® (pronounced ‘RENEW’) Lung Volume Reduction Coil (LVRC), a medical implant designed to treat the symptoms of emphysema. RENEW is a multicenter, randomized trial that will investigate the safety and effectiveness of the RePneu LVRC based on exercise capacity, improved lung function and quality of life. The trial expects to enroll 315 patients in approximately 30 medical centers across North America, including a few sites in Europe.
Ganesh Krishna, MD, principal investigator and interventional pulmonologist at El Camino Hospital and Palo Alto Medical Foundation, said, "Emphysema is a progressive disease with no cure and very limited treatment options. El Camino Hospital is excited to contribute to the study and evaluation of the RePneu LVRC implant, which could be a new treatment approach for patients suffering with this debilitating condition."
The RENEW trial is enrolling patients who have been clinically diagnosed with severe emphysema and are experiencing increasing difficulty with simple daily tasks. Patients must be over 35 years of age, must have stopped smoking for at least eight weeks and must have completed a pulmonary rehabilitation program within six months and/or be on a maintenance program.
If the RePneu LVRC is approved by the Food & Drug Administration (FDA), it may offer a minimally invasive treatment option for patients in the U.S. suffering with severe emphysema. Though RePneu LVRC is investigational in the U.S., the device has been used for treatment of severe emphysema in patients in Europe since 2008.
About Advanced Emphysema
Over three million1 Americans suffer from advanced emphysema, a chronic, debilitating disease most commonly brought on by years of smoking. Emphysema causes irreversible damage to delicate lung tissue, leading to shortness of breath and even feelings of suffocation that result in diminished quality of life. Emphysema is medically characterized by reduced lung function, increased lung volume and loss of the lung’s natural elasticity, which makes breathing very difficult.
As the disease progresses and lung tissue is destroyed, excess air is trapped in the lungs making it difficult for the person to exhale. This process is known as hyperinflation and is responsible for the feeling of being "short of breath." Patients with severe emphysema experience shortness of breath nearly all the time, even when resting, and suffer from continuous fatigue, chronic coughing, wheezing and frequent respiratory infections. Patients are also at higher risk for lung infection, inflammation and other respiratory conditions, as well as serious other systemic conditions such as diabetes2 and heart disease3.
As there is no cure for emphysema, the goal of current treatment methods such as drug therapy (inhaled steroids, bronchodilators and antibiotics), supplemental oxygen (oxygen tank) and pulmonary rehabilitation (breathing exercises) is to relieve symptoms and teach people how to live with the disease. Eventually, the disease will exhaust these treatment methods, leaving the patient with very few options to relieve symptoms4.
About Fogarty Clinical Research
Fogarty Clinical Research (FCR), affiliated with the Fogarty Innovation Institute, is a dedicated research site on the campus of El Camino Hospital in Mountain View, CA. FCR serves to bring innovative treatment options to the community through effective and responsible clinical research. FCR fosters collaboration between investigators, healthcare institutions, and industry leaders in order to provide the community with the most advanced treatment options available. To learn more about the organization, visit www.fogartyclinicalresearch.com.
About El Camino Hospital
El Camino Hospital is an acute-care, 443-bed, nonprofit and locally governed organization with campuses in Mountain View and Los Gatos, Calif. In addition to state-of-the-art emergency departments, key medical specialties include neuroscience, heart and vascular, cancer care, urology, orthopedic and spine, genomic medicine, and the only Women's Hospital in Northern California. The hospital is recognized as a national leader in the use of health information technology and wireless communications, and has been awarded the Gold Seal of Approval from The Joint Commission as a Primary Stroke Center as well as back-to-back ANCC Magnet Recognitions for Nursing Care.
2. Emma H Baker MD and Derek Bell MD. Blood glucose: of emerging importance in COPD exacerbations. Thorax 2009;64:830-832.
3. Kaiser Permanente Medical Care Program. COPD and Incident Cardiovascular Disease Hospitalizations and Mortality. Chest 2005: 128: 2068-075
4. Centers for Disease Control and Prevention. Chronic Obstructive Pulmonary Disease Surveillance – United States, 1971-2000. Morbidity and Mortality Weekly Report. August 2, 2002; 51(SS06):1-16.