Uptake Medical said today it won CE Mark approval in the European Union for its InterVapor ablation device, now indicated to treat patients who suffer from severe emphysema.
The InterVapor device uses heated water vapor to reduce bronchoscopic lung volume in patients with heterogenous upper lobe emphysema, the Tustin, Calif.-based company said.
“The traditional treatment options for severe emphysema patients have been very limited which is why we have remained committed over the past decade to finding a more meaningful treatment alternative for this progressive disease. Gaining CE Mark is a major milestone for our company, but more importantly, represents new hope for emphysema patients. We are eager to begin the commercial launch of InterVapor in Europe allowing more interventional pulmonologists to begin using the system in the months ahead,” CEO King Nelson said in a press release.
The new CE Mark indication follows from the company’s Step-Up trial, which evaluated the safety and performance of the InterVapor device in addition to optimal medical standard therapy to improve lung performance and quality of life in severe emphysema patients, the company said.
Results from the trail will be reported at the European Respiratory Society meeting in Amsterdam in late September.
“Being granted the CE Mark validates for Uptake Medical the merits of our clinical hypothesis to have for the first time an option where we can treat the most diseased segments and preserve the less diseased segments,” co-principal investigator Dr. Med Felix Herth of Heidelberg, Germany’s Thorax Klinik said in a prepared statement.