Uptake Medical's InterVapor system for emphysema wins EU approval

29 September 2011

Uptake Medical has received the CE Mark (Conformité Européenne) for its InterVapor System for the treatment of severe emphysema. The company says it is the first endoscopic lung volume reduction system that uses the body’s natural healing processes without leaving foreign materials behind.

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.”

Source: Uptake Medical

 

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