Uptake Medical said today that data from a study recently published in the journal Lancet indicated that patients who underwent therapy using the company’s InterVapor system experienced statistically significant benefits in both lung function and quality of life.
The InterVapor uses heated water vapor to reduce bronchoscopic lung volume in patients with heterogenous upper lobe emphysema, the company said.
The results are from the company’s Step-Up randomized, controlled, multi-center, multi-national study designed to evaluate the safety and performance of its Intervapor system.
“Non-surgical bronchoscopic lung volume reduction has gained clinical traction because the interventions are minimally invasive, with reduced mortality and morbidity when compared to traditional lung volume reduction surgery,” lead author Felix Herth of the Thoraxklinik said in a press release. “The Step-Up study, which involved a staged treatment strategy targeting only the more diseased segments of an upper lobe, has shown that bronchoscopic lung volume reduction as a treatment approach leads to statistically and clinically significant improvements compared with standard care. It allows for precise targeting of only the more diseased segments of a lobe, and enables clinicians to take a personalized approach to treating a patient’s most diseased segments at the initial stage, assessing their response, and then considering further treatment on an individual basis.”
The Step-Up trial evaluated 70 patients between 45-75 with severe upper-lobe predominant emphysema and a forced expiratory volume between 20% and 45%. Patients in the InterVapor cohort had a mean relative improvement in lung function, rated by FEV1, of 10.1% at 3 months and 14.7% at 6 months.
Quality of health improved by 9.7% for patients treated with the InterVapor system, and study authors reported that treated patients showed forced statistically improved vital capacity and residual volume.
“The publication of these groundbreaking clinical results in The Lancet is just the latest reaffirmation of InterVapor as a safe and effective treatment option for severe emphysema patients. The article’s authors note that other lung volume reduction therapies may decline in effectiveness over time, but InterVapor’s targeted vapor ablation therapy leads not only to clinically meaningful improvements, but the potential for additional future treatments to help patients suffering from this progressive, debilitating condition,” CEO King Nelson said in prepared remarks.
In January, Uptake Medical said it launched a registry trial of its InterVapor system to investigate long-term clinical results in severe emphysema patients.
Patients enrolled in the registry trial will be asked to return for follow-up visits to assess lung function and quality of life, the Tustin, Calif.-based company said.