and TUSTIN, Calif.
, Sept. 26, 2011
/PRNewswire/ -- Uptake Medical® today announced it has received the CE Mark (Conformite Europeenne) for the InterVapor System - the first endoscopic lung volume reduction system for the treatment of severe emphysema that uses the body's natural healing processes without leaving foreign materials behind. The CE Mark will allow Uptake Medical to commercialize InterVapor in key markets within the European Community.
This announcement coincides with the presentation of the six-month results from the worldwide, multi-center VAPOR trial at the European Respiratory Society Annual Congress. The clinical trial data shows significant improvement in breathing capacity, shortness of breath, exercise capacity and quality of life. The results of this trial were presented during clinical sessions at the European Respiratory Society's Annual Congress on Sunday, September 25, 2011 at 10:45 AM in Amsterdam.
Emphysema is a progressive disease in which the lungs are permanently damaged. This leads to a condition called hyperinflation, which impacts breathing function and forces patients to take short, shallow breaths, severely impacting quality of life. The InterVapor System was developed in response to the needs of patients with severe emphysema and is designed to directly target the hyperinflation in the lungs.
The VAPOR study was an open label, single-arm trial of InterVapor (Bronchoscopic Thermal Vapor Ablation) in patients with upper lobe predominant emphysema. Primary endpoints measuring lung function improvement (FEV1) and health-related quality of life (St. George's Respiratory Questionnaire or SGRQ) achieved both statistical and clinical significance at six months. Additionally, 83 percent of patients met a combined endpoint for clinical improvement.
Efficacy was consistently demonstrated across all endpoints. Secondary endpoints demonstrated that patients treated with the InterVapor procedure have significant physiologic improvements (including decreased hyperinflation and gas trapping) as well as clinical improvements (reduced breathlessness and improved exercise capacity). All treatments were performed successfully without intra-procedural complications. Adverse events related to treatment included a temporary increase in respiratory symptoms in some patients, which generally resolved with standard medical management. Clinical data supports a favorable risk/benefit profile for the use of InterVapor in the treatment of patients with heterogeneous severe emphysema.
Felix Herth, MD, Chief, Department of Pulmonary Medicine, Thoraxklinik Heidelberg and primary investigator for the VAPOR study, is enthusiastic about the InterVapor data. "In a progressive and debilitating disease such as emphysema, it is important to show improvement across multiple measures as each metric indicates a different aspect of emphysema. A procedure that shows an 83 percent improvement when looking at several endpoints should provide new optimism for patients who are living with emphysema."
InterVapor is a minimally invasive procedure which treats hyperinflated parts of the lungs with heated water vapor. InterVapor triggers the body's natural healing process, gradually reducing the treated portion of the lungs and increasing the ability to breathe more fully. Unlike other approaches to lung volume reduction, InterVapor requires no foreign materials to be left behind in the lung which may require additional procedures.
King Nelson, President and Chief Executive Officer of Uptake Medical, stated, "We are extremely pleased to have received the CE Mark for InterVapor and continue to be encouraged by the positive results from our InterVapor technology. As the only endoscopic lung volume reduction procedure that uses a natural healing process without leaving foreign materials in the lung, we believe that InterVapor will play an important role in advancing treatments for emphysema. We have a unique opportunity to help patients with severe emphysema and we look forward to having the InterVapor System available to physicians and their patients."
The clinical trial investigators are Felix Herth, MD, Gregory Snell, MD, Peter Hopkins, MD, Kimberly Baker, MD, Christian Witt, MD, Mark H. Gotfried, MD, Arschang Valipour, MD, Manfred Wagner, MD, Franz Stanzel, MD, James Egan, MD, Steven Kesten, MD and Armin Ernst, MD. The results of the clinical trial were presented at the European Respiratory Society Annual Congress in the session titled, "Sustained Efficacy From 3 to 6 Months Following Bronchoscopic Thermal Vapor Ablation (BTVA) in the Treatment of Heterogeneous Emphysema" (abstract number 370) on Sunday, September 25, 2011, at 10:45 AM. A press conference discussing the results will be held on Monday, September 26, 2011, at 2:30 PM.
The global incidence of Chronic Obstructive Pulmonary Disease (COPD), which includes emphysema, is on the rise, on pace to become the third leading cause of death by 2030. In the US, where nearly 5 million people are diagnosed with emphysema, it already holds this position with one person dying every 4 minutes. Debilitating and costly, nearly $50 billion was spent addressing the direct and indirect costs associated with COPD in the US in 2010.
About Uptake Medical
With headquarters in Tustin, CA, Uptake Medical® develops innovative medical technologies for the treatment of lung diseases. Its first product, InterVapor, is the first and only approach to endoscopic lung volume reduction for people with severe emphysema that uses the body's natural healing process without leaving any foreign materials in the lung. In clinical studies, InterVapor has demonstrated clinically meaningful improvements in breathing function, exercise capacity and quality of life. InterVapor received the CE mark in September 2011 and plans to commercialize (in Europe and Australia) over the coming months. More information can be found at www.uptakemedical.com.
Uptake Medical, InterVapor, InterVapor Personalized Procedure Program and IP3 are registered trademarks and trademarks of Uptake Medical.
SOURCE Uptake Medical